Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 4:10 AM
Study NCT ID:
NCT04574635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment', 'timeFrame': 'At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)', 'description': 'The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.'}], 'secondaryOutcomes': [{'measure': 'ctDNA levels', 'timeFrame': 'Baseline', 'description': 'Will be associated with Federation of Gynecology and Obstetrics stage and assessed using linear regression, reporting the correlation as well as the model estimates.'}, {'measure': 'Clinical tumor response', 'timeFrame': 'At post-treatment assessment, assessed up to 2 years', 'description': 'Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.'}, {'measure': 'Radiographic tumor response', 'timeFrame': 'At post-treatment assessment, assessed up to 2 years', 'description': 'Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.'}, {'measure': 'Recurrence-free survival', 'timeFrame': 'Up to 2 years', 'description': 'Baseline ctDNA and ctDNA at measured time points will be considered in Cox models.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 2 years', 'description': 'Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.'}, {'measure': 'ctDNA clearance kinetics', 'timeFrame': 'Up to 2 years', 'description': 'Will be correlated with recurrence-free survival. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.'}, {'measure': 'ctDNA conversion', 'timeFrame': 'Up to 2 years', 'description': 'Will be correlated during the active monitoring phase with recurrence-free survival.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Adenosquamous Carcinoma', 'Cervical Squamous Cell Carcinoma, Not Otherwise Specified', 'Infiltrating Cervical Carcinoma', 'Metastatic Cervical Carcinoma', 'Recurrent Cervical Carcinoma', 'Stage I Cervical Cancer FIGO 2018', 'Stage IA Cervical Cancer FIGO 2018', 'Stage IA1 Cervical Cancer FIGO 2018', 'Stage IA2 Cervical Cancer FIGO 2018', 'Stage IB Cervical Cancer FIGO 2018', 'Stage IB1 Cervical Cancer AJCC v8', 'Stage IB2 Cervical Cancer FIGO 2018', 'Stage IB3 Cervical Cancer FIGO 2018', 'Stage II Cervical Cancer FIGO 2018', 'Stage IIA Cervical Cancer FIGO 2018', 'Stage IIA1 Cervical Cancer FIGO 2018', 'Stage IIA2 Cervical Cancer FIGO 2018', 'Stage IIB Cervical Cancer FIGO 2018', 'Stage III Cervical Cancer FIGO 2018', 'Stage IIIA Cervical Cancer FIGO 2018', 'Stage IIIB Cervical Cancer FIGO 2018', 'Stage IIIC Cervical Cancer FIGO 2018', 'Stage IIIC1 Cervical Cancer FIGO 2018', 'Stage IIIC2 Cervical Cancer FIGO 2018', 'Stage IV Cervical Cancer FIGO 2018', 'Stage IVA Cervical Cancer FIGO 2018', 'Stage IVB Cervical Cancer FIGO 2018']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women ages 18 and older presenting with p16-positive or HPV-positive invasive carcinoma of the cervix cancer with plan to undergo therapy at Mayo Clinic Rochester or the University of Minnesota.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written consent\n* Patient has given permission to give tumor/blood sample for research testing\n* Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix\n* Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV\n* Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits\n* Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis\n* Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)\n\n * FIGO 2019 Stage IB2-IIIC or not a surgical candidate\n * Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy\n\nExclusion Criteria:\n\n* Other active malignancy =\\< 2 years prior to registration.\n\n * EXCEPTIONS: Non-melanotic skin cancer\n * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer\n* Pregnancy or lactation\n* Inability on the part of the patient to understand the informed consent to be compliant with the protocol'}, 'identificationModule': {'nctId': 'NCT04574635', 'briefTitle': 'Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer', 'orgStudyIdInfo': {'id': 'ROR1905'}, 'secondaryIdInfos': [{'id': 'NCI-2020-06965', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ROR1905', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}, {'id': '19-011924', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Definitive chemoradiotherapy patients', 'description': 'Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).', 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of blood samples', 'armGroupLabels': ['Definitive chemoradiotherapy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Allison E. Garda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}