Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05462951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2022-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker', 'timeFrame': '3 months posttherapy', 'description': 'deoxyribonucleotide levels'}, {'measure': 'Biomarker', 'timeFrame': '3 months posttherapy', 'description': 'HPV DNA levels'}, {'measure': 'Biomarker', 'timeFrame': '3 months posttherapy', 'description': 'Circulating tumor cell count'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Uterine Cervix Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (\\> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.\n\nExclusion Criteria:\n\n* Presence of another concurrent active invasive malignancy\n* Prior invasive malignancy diagnosed within the last three years except for \\[1\\] non-melanoma skin cancer or \\[2\\] prior in situ carcinoma of the cervix\n* prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.'}, 'identificationModule': {'nctId': 'NCT05462951', 'briefTitle': 'Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer', 'orgStudyIdInfo': {'id': 'MCC-22-GYN-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiochemotherapy followed by brachytherapy', 'description': 'Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy', 'interventionNames': ['Radiation: Standard']}], 'interventions': [{'name': 'Standard', 'type': 'RADIATION', 'description': 'Radiation then brachytherapy', 'armGroupLabels': ['Radiochemotherapy followed by brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Denise Fabian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denise Fabian', 'class': 'OTHER'}, 'collaborators': [{'name': 'UK Radiopharma Alliance', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Denise Fabian', 'investigatorAffiliation': 'University of Kentucky'}}}}