Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-12 @ 7:11 AM
Study NCT ID:
NCT03319251
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Database Registry for Photodynamic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected on the date of Photodynamic Therapy. A total of 13.5mL of blood will be collected between 2 tubes (3.5mL gold top tube and a 10 mL lavendar top Vacutainer tube with EDTA). The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actinic Keratosis (AK) clearance', 'timeFrame': 'at 3 months post-treatment', 'description': 'Change in AK lesions present at 3 months post-PDT treatment'}, {'measure': 'Vitamin D levels', 'timeFrame': 'At baseline, which is the day of PDT treatment', 'description': 'Vitamin D level (25-hydroxy-cholecalciferol) measured in serum'}], 'secondaryOutcomes': [{'measure': 'Allele polymorphisms in the gene of the Vitamin D receptor (VDR)', 'timeFrame': 'At baseline, which is the day of PDT treatment', 'description': 'Identify the allele combination present at VDR locus'}, {'measure': 'Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme', 'timeFrame': 'At baseline, which is the day of PDT treatment', 'description': 'Identify the allele combination present at TS locus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '35932960', 'type': 'DERIVED', 'citation': 'Heusinkveld LE, Bullock TA, Negrey J, Warren CB, Maytin EV. Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis. Photodiagnosis Photodyn Ther. 2022 Dec;40:103050. doi: 10.1016/j.pdpdt.2022.103050. Epub 2022 Aug 3.'}, {'pmid': '35314199', 'type': 'DERIVED', 'citation': 'Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.", 'detailedDescription': "Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training.\n\nDNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years.\n\nBlood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field.\n\nThe Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing.\n\nInformation will not be disclosed to third party outside of Cleveland Clinic for research purposes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The desired population for this study is 100 patients who have at least 10 nonhypertrophic actinic keratosis lesions present on the face, scalp, forearms, chest, or legs and are scheduled to receive Photodynamic Therapy (PDT) at the Cleveland Clinic noninvasive cutaneous oncology clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females, at least 18 years of age\n* Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment\n\nExclusion Criteria:\n\n* taking doxycline, a photosensitizer\n* using topical retinoids, since these can exacerbate the post-PDT erythema reaction\n* pregnant'}, 'identificationModule': {'nctId': 'NCT03319251', 'briefTitle': 'Biomarker Database Registry for Photodynamic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Biomarkers of Clinical Responsiveness to Photodynamic Therapy', 'orgStudyIdInfo': {'id': '16-1615'}}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Edward Maytin, MD, PhD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}