Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06456112
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
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': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The one-year probability of OS', 'timeFrame': 'one year', 'description': 'OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '1 month post treatment', 'description': 'progression free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients.', 'detailedDescription': 'Cervical cancer has a very clear etiology, with the vast majority of cases being caused by persistent and repeated infections with high-risk HPV. In the carcinogenic mechanism of cervical cancer, there are large amounts of HR-HPV integrated into the human genome in cancer cells; these HR-HPV can be released into the bloodstream in the form of ctHPV, and most patients with stages I-IV of cervical cancer can have detectable ctHPV in their blood. Among them, the detection rate in the blood of late-stage patients ranges from 63.3% to 100%. Several studies have demonstrated that ctHPV may serve as a marker for monitoring recurrent tumor molecular residual lesions, which could be of significant importance for prognostic evaluation and monitoring whether the disease has recurred. In this study, we will systematically evaluate the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cervical cancer patients diagnosed with HPV16 or HPV18 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women, aged between 18 and 75 years, can receive standard treatment, including patients who only receive surgery, and patients who receive radiotherapy and chemotherapy after surgery.\n2. Cervical cancer caused by HPV16 or HPV18 infection diagnosed by molecular biology or pathological tissue (p16), with pathological stage of IB1 to IV.\n\n \\-\n\nExclusion Criteria:\n\n1. Patients with other malignancies\n2. Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease\n3. Cervical cancer patients who had undergone LEEP knife or conization in primary hospitals\n4. Cervical cancer patients whose peripheral blood was negative for ctHPV at baseline. Here, ctHPV negative refers to patients who are both negative for ddPCR and NGS'}, 'identificationModule': {'nctId': 'NCT06456112', 'briefTitle': 'Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV', 'orgStudyIdInfo': {'id': 'YingZhou 2024-7'}}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Ying Zhou, MD', 'role': 'CONTACT', 'email': 'caddiezy@ustc.edu.cn', 'phone': '+8613865901025'}], 'facility': 'Anhui Provincal Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Ying Zhou, MD', 'role': 'CONTACT', 'email': 'caddiezy@ustc.edu.cn', 'phone': '+8613865901025'}], 'overallOfficials': [{'name': 'Ying Zhou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}