Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT05743959
Status:
RECRUITING
Last Update Posted:
2023-05-22
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The primary endpoint for this study is Relapse-free survival (RFS), which will be assessed using RECIST version 1.1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholangiocarcinoma', 'ctDNA', 'Minimal Residual Disease (MRD)'], 'conditions': ['Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': "A substantial proporation of patients with biliary tract malignancies still experience disease recurrence after curative resection. ctDNA-based minimal residual disease (MRD) method has been widely used to monitor postoperative recurrence in solid cancers, but few studies have been reported in biliary tract cancers.\n\nThe present clinical trial aims to elucidate the correlation between the postoperative ctDNA status and the prognosis of patients with biliary tract cancers, and evaluate whether ctDNA could better predict patients' recurrence and guide clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage I-III biliary duct cancer eligible for curative surgical resection', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age on the day of signing informed consent.\n2. Clinically diagnosed as BTC before surgery and confirmed by pathology after surgery.\n3. Stage I-III tumor according to the UICC/AJCC TNM staging system (8th edition in 2017), meeting the indications for radical surgery and are planned to undergo radical treatment. Those who do not undergo radical surgery will be excluded.\n4. Patients must have a performance status of ≤1 on the ECOG Performance Scale.\n5. Patients must have survival of \\> 6 months after surgery\n6. Serological tumor indicators (CEA, CA19-9) and imaging data ( CT and/or MRI, PET-CT) were complete.\n7. Blood biochemical indicators meet surgical standards\n8. Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Patients with recurrent biliary tract tumors\n2. Patients with hepatobiliary mixed tumors\n3. Patients with malignant tumors of other organs that have not been cured before.\n4. History of organ transplant or allogeneic stem cell transplant\n5. Patients with severe infections that are active or poorly controlled clinically\n6. patients who are cognitively impaired or with known psychiatric disorders, and/or substance abuse\n7. pregnant or lactating women\n8. Failed to sign informed consent\n9. Other conditions that researchers judged inappropriate for inclusion"}, 'identificationModule': {'nctId': 'NCT05743959', 'briefTitle': 'ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial', 'orgStudyIdInfo': {'id': 'Dominant_2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with stage I-III biliary tract cancers', 'description': 'Patients with stage I-III biliary tract cancers eligible for curative surgical resection', 'interventionNames': ['Procedure: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'PROCEDURE', 'description': 'No intervention', 'armGroupLabels': ['Patients with stage I-III biliary tract cancers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangcheng Li, PhD', 'role': 'CONTACT', 'email': 'drlixc@163.com', 'phone': '+8618951999088'}, {'name': 'Xiaofeng Chen, PhD', 'role': 'CONTACT', 'email': '13585172066@126.com', 'phone': '+8613585172066'}], 'facility': 'The First Affiliated Hospital with NanJing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xiangcheng Li, PhD', 'role': 'CONTACT', 'email': 'drlixc@163.com', 'phone': '+8618951999088'}, {'name': 'Xiaofeng Chen, PhD', 'role': 'CONTACT', 'email': '13585172066@126.com', 'phone': '+8613585172066'}], 'overallOfficials': [{'name': 'Xiangcheng Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}