Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06404593
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-05', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-05-05', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '1 year'}, {'measure': 'overall survival', 'timeFrame': '5 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimal Residual Disease', 'Colorectal Liver Metastases'], 'conditions': ['Liver Metastases', 'Colorectal Cancer', 'Surgery', 'Circulating Tumor DNA', 'Minimal Residual Disease']}, 'descriptionModule': {'briefSummary': 'Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study enrolled patients with colorectal liver metastases undergoing radical resection at Hepatopancreatobiliary Surgery Department I of Peking University Cancer Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Before implementing any trial-related procedures, written informed consent should be signed;\n2. \\>=20 and \\<= 85 years old, male or female;\n3. Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;\n4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;\n5. The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;\n6. The general physical condition is good (ECOG score 0-1);\n7. Life expectancy of more than 3 months;\n8. There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;\n9. adequate organ function;\n10. samples meet NGS quality control requirements;\n11. The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.\n\nExclusion Criteria:\n\n1. Patients who are intolerant to systemic chemotherapy or surgery;\n2. Patients with multiple primary lesions;\n3. Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);\n4. Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements\n5. Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up\n6. Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection\n7. No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.'}, 'identificationModule': {'nctId': 'NCT06404593', 'briefTitle': 'Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Dynamic ctDNA Detection for Guiding Adjuvant Therapy and Recurrence Monitoring After Curative Resection of Colorectal Cancer Liver Metastases: A Prospective Study', 'orgStudyIdInfo': {'id': 'PKUCRLM-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Blood sampling 7 days after surgery', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Group 2', 'description': 'Blood sampling 1 month after surgery', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Group 3', 'description': 'Blood sampling 3 to 6 months after surgery', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Group 4', 'description': 'Blood sampling 6 to 9 months after surgery', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Group 5', 'description': 'Blood sampling 9 to 12 months after surgery', 'interventionNames': ['Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}