Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-02 @ 8:18 AM
Study NCT ID:
NCT02165605
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sarmistha.Sen@UTSouthwestern.edu', 'phone': '214-645-1477', 'title': 'Sarmistha Sen', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The independent panel (two radiation oncologists and two breast surgeons) evaluated photographs of the breasts taken at week 5 during and 2 weeks post-RT', 'description': 'Expected adverse event due to radiation with and without the skin cream (Hylacare).\n\n* Erythema\n* Pain\n* Tenderness\n* Irritability\n* Burning\n* Dryness\n* Hypersensitivity\n* Hair loss', 'eventGroups': [{'id': 'EG000', 'title': 'Expected Adverse Events With and Without Skin Cream(Hylacare)', 'description': 'Expected adverse event due to radiation with and without the skin cream (Hylacare).\n\n* Erythema\n* Pain\n* Tenderness\n* Irritability\n* Burning', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 14, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Desquamation', 'notes': 'HA serum: 6 participants (21%) Placebo: 8 participants (29%)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Skin Toxicity Per NCI-CTC v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HylaCare', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Grade ≥3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 patients were assigned to both arms HA formulation (Hylacare study cream) on the medial or lateral half of the irradiated breast and the control cream (placebo) on the other half. Each patient will use both HA study cream and placebo cream on breast receiving radiation treatment.'}, {'type': 'PRIMARY', 'title': 'Acute Skin Toxicity Per NCI-CTC v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HylaCare', 'description': 'HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.\n\nHylaCare: cream'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The patient is her own control.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade ≥ 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2 post-radiation therapy', 'description': 'NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We only analyze available data'}, {'type': 'PRIMARY', 'title': 'Acute Skin Toxicity Per Investigator Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HylaCare', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Grade ≥ 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin\n\n1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema\n2. = erythema with dry desquamation\n3. = wet desquamation \\</= 2 cm\n4. = wet desquamation from 2.1 - 5cm\n5. = wet desquamation from 5.1 - 9 cm\n6. = wet desquamation \\> 9.1 cm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acute Skin Toxicity Per Investigator Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HylaCare', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Grade ≥3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2 post-radiation therapy', 'description': 'Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with\n\n0 = normal skin\n\n1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema\n2. = erythema with dry desquamation\n3. = wet desquamation \\</= 2 cm\n4. = wet desquamation from 2.1 - 5cm\n5. = wet desquamation from 5.1 - 9 cm\n6. = wet desquamation \\> 9.1 cm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We only analyzed data that were available'}, {'type': 'SECONDARY', 'title': 'Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HylaCare', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.'}], 'classes': [{'categories': [{'title': 'Skin reaction', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No Skin reaction', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'Acute skin toxicity, as measured by number of participants with skin reactions via self assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HA Serum Vs. Control Cream (Placebo)', 'description': 'Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the other breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within 4 hours prior to radiation treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hylacare-Experimental', 'description': 'HylaCare cream-Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. The patient is her own control.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-07', 'size': 871897, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-18T17:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2013-12-19', 'resultsFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-28', 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Skin Toxicity Per NCI-CTC v4.0', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.'}, {'measure': 'Acute Skin Toxicity Per NCI-CTC v4.0', 'timeFrame': 'Week 2 post-radiation therapy', 'description': 'NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.'}, {'measure': 'Acute Skin Toxicity Per Investigator Grading Scale', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin\n\n1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema\n2. = erythema with dry desquamation\n3. = wet desquamation \\</= 2 cm\n4. = wet desquamation from 2.1 - 5cm\n5. = wet desquamation from 5.1 - 9 cm\n6. = wet desquamation \\> 9.1 cm'}, {'measure': 'Acute Skin Toxicity Per Investigator Grading Scale', 'timeFrame': 'Week 2 post-radiation therapy', 'description': 'Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with\n\n0 = normal skin\n\n1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema\n2. = erythema with dry desquamation\n3. = wet desquamation \\</= 2 cm\n4. = wet desquamation from 2.1 - 5cm\n5. = wet desquamation from 5.1 - 9 cm\n6. = wet desquamation \\> 9.1 cm'}], 'secondaryOutcomes': [{'measure': 'Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions', 'timeFrame': 'Week 5 during radiation therapy', 'description': 'Acute skin toxicity, as measured by number of participants with skin reactions via self assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['external beam radiotherapy', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31273506', 'type': 'DERIVED', 'citation': 'Rahimi A, Mohamad O, Albuquerque K, Kim DWN, Chen D, Thomas K, Wooldridge R, Rivers A, Leitch M, Rao R, Haley B, Ahn C, Garwood D, Spangler A. Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1481-1489. doi: 10.1007/s00520-019-04957-0. Epub 2019 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.', 'detailedDescription': 'Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, age 18 or older\n* Diagnosis of breast cancer\n* Intact breast (not surgically absent)\n* Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)\n* Ability to understand and comply with the requirements of this study\n* Ability to give Informed Consent\n* For sexually active females, patient agrees to use acceptable method of birth control\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Use of concomitant skin care preparations at any of the treated or control portal areas to be observed\n* Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis\n* Severe renal failure creatinine \\> 3.0 within 6 months of study registration\n* Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo\n* Planned relocation which would make follow-up visits impossible during the course of the study\n* Collagen vascular disease such as Lupus, or scleroderma'}, 'identificationModule': {'nctId': 'NCT02165605', 'briefTitle': 'HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.', 'orgStudyIdInfo': {'id': 'STU 092012-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HylaCare', 'description': 'HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.', 'interventionNames': ['Drug: HylaCare']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patient is her own control.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HylaCare', 'type': 'DRUG', 'description': 'cream', 'armGroupLabels': ['HylaCare']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75239', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Asal Rahimi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Asal Rahimi', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}