Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 4:44 PM
Study NCT ID:
NCT05752357
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of disease recurrence', 'timeFrame': 'Baseline', 'description': 'Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.'}, {'measure': 'Percentage of disease recurrence', 'timeFrame': 'Post-operation within 3 days', 'description': 'Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.'}, {'measure': 'Percentage of disease recurrence', 'timeFrame': 'Post-operation day 4 - 4 weeks', 'description': 'Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.'}, {'measure': 'Percentage of disease recurrence', 'timeFrame': 'Post-operation 3 months', 'description': 'Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.'}, {'measure': 'Percentage of disease recurrence', 'timeFrame': 'Post-operation 6 months', 'description': 'Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.'}], 'secondaryOutcomes': [{'measure': 'Percentage of peritoneal seedings', 'timeFrame': 'Baseline', 'description': 'Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.'}, {'measure': 'Percentage of peritoneal seedings', 'timeFrame': 'Post-operation within 3 days', 'description': 'Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.'}, {'measure': 'Percentage of peritoneal seedings', 'timeFrame': 'Post-operation day 4 - 4 weeks', 'description': 'Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.'}, {'measure': 'Percentage of peritoneal seedings', 'timeFrame': 'Post-operation 3 months', 'description': 'Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.'}, {'measure': 'Percentage of peritoneal seedings', 'timeFrame': 'Post-operation 6 months', 'description': 'Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.'}, {'measure': 'overall survival time', 'timeFrame': 'Post-operation 1 year.', 'description': 'To correlate the relationship of circulating tumor cells and long-term survival time.'}, {'measure': 'overall survival time', 'timeFrame': 'Post-operation 2 year.', 'description': 'To correlate the relationship of circulating tumor cells and long-term survival time.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Post-operation 1 year.', 'description': 'To correlate the relationship of circulating tumor cells and Progression-free survival.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Post-operation 2 year.', 'description': 'To correlate the relationship of circulating tumor cells and Progression-free survival.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating tumor cells', 'gastric cancer', 'peritoneal carcinomatosis', 'recurrence', 'metastasis'], 'conditions': ['Carcinoma']}, 'descriptionModule': {'briefSummary': "In resectable gastric cancer participants who received curative surgery, to early and more accurately detect peritoneal carcinomatosis or occult metastasis is important. Also, investigators will look at CTC numbers in different timings after operation, to investigate the possibility of early detection for peritoneal carcinomatosis or occult metastasis. Also, this study will correlate the relationship of CTC and participants' survival.", 'detailedDescription': 'Circulating tumor cells (CTCs) are an emerging "liquid biopsy" that provide prognostic value for various types of solid cancer on early recurrence and survival. The evaluation of CTCs might be a useful strategy to predict tumor progression and prognosis in Gastric adenocarcinoma (GC). Previous study has shown that the frequency of CTC detection was higher in advanced GC than early GC, in poorly differentiated GC than well/moderately differentiated GC, and in GC with lymphatic metastasis than that without lymphatic metastasis. However, the impact of CTCs in the detection of PM in GC is still under debate. Peritoneal metastasis (PM) is highly related to recurrence and metastasis in GC; therefore, it was significantly related to disease free and overall survival of participants.\n\nConsequently, several important questions and goals will be answered by this study:\n\nTo elucidate the clinical relationship between CTCs and PM in GCs before the operation; therefore, it could be an indicator of prophylactic during operation, which may possibly prolong the disease free and overall survival.\n\nTo establish a good model to follow-up a specific surface marker on CTCs, which could be possibly utilized as a more sensitive marker, comparing with CEA or image study, to more accurately detect the early recurrence or metastasis in GC.\n\nTo verify that dynamically monitoring CTCs status and changes during long-term follow-up and anti-cancer treatment are feasible and clinically meaningful to survival or treatment responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Enrolling 150 cases\n* Stage I or more advanced gastric cancer, pathology proved\n* Diagnosed at age ≥ 20 years\n* Enrolled before surgery at the General Surgery Department, both inpatient and outpatient services.\n\nExclusion Criteria:\n\n* Patient's refusal\n* Poor compliance, unable to cooperate for blood sampling for CTC isolation as time schedule or clinical treatment or follow-up\n* Difficult blood sampling\n* No more needs for CTCs evaluation, decided by clinicians."}, 'identificationModule': {'nctId': 'NCT05752357', 'briefTitle': 'The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Does Circulating Tumor Cells Provide Diagnostic and Prognostic Roles in Peritoneal Carcinomatosis, Recurrence and Metastasis in Gastric Cancer, Pre-operatively and Postoperatively?', 'orgStudyIdInfo': {'id': '202100832B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single arm, observational arm', 'description': 'Patients who received surgery will routinely followed up by pre-op CTC, post-op CTC until 6 months after surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Chun Chang', 'role': 'CONTACT', 'email': 'b9302071@cgmh.org.tw', 'phone': '+886 975361360'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'Shih-Chun Chang', 'role': 'CONTACT', 'email': 'b9302071@cgmh.org.tw', 'phone': '+886 975361360'}, {'name': 'Chia-Hsun Hsieh', 'role': 'CONTACT', 'email': 'wisdom5000@gmail.com', 'phone': '+886 975366137'}], 'overallOfficials': [{'name': 'Shih-Chun Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}