Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT03972956
Status:
RECRUITING
Last Update Posted:
2022-04-29
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D006547', 'term': 'Hernia'}], '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': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biospecimens will be analyzed to study, but not limited to, genomics, epigenomics, and proteomics.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of diagnosis by pathologist', 'timeFrame': 'Up to 3 years', 'description': 'Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Gastric Cancer', 'Inflammatory Bowel Diseases', 'Gastric Ulcer', 'Hemorrhoids', 'Hernia']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who are planning to undergo surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.\n* Must be willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.'}, 'identificationModule': {'nctId': 'NCT03972956', 'briefTitle': 'Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease', 'organization': {'class': 'OTHER', 'fullName': 'Renmin Hospital of Wuhan University'}, 'officialTitle': 'Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery', 'orgStudyIdInfo': {'id': 'SAMPGICUS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal cancer or gastric cancer patient', 'description': 'Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach.', 'interventionNames': ['Other: No intervention will be given to patients.']}, {'label': 'Non-malignant disease patient', 'description': 'Patients suffering from non-malignant disease scheduled to have surgery.', 'interventionNames': ['Other: No intervention will be given to patients.']}], 'interventions': [{'name': 'No intervention will be given to patients.', 'type': 'OTHER', 'description': 'Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.', 'armGroupLabels': ['Colorectal cancer or gastric cancer patient', 'Non-malignant disease patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Fu, MD', 'role': 'CONTACT', 'email': 'futao1975@tom.com', 'phone': '86-13720120190'}], 'facility': 'Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Tao Fu, MD', 'role': 'CONTACT', 'email': 'tfu001@whu.edu.cn', 'phone': '+8613720120190'}], 'overallOfficials': [{'name': 'Tao Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renmin Hospital of Wuhan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of GI Surgery II', 'investigatorFullName': 'Tao Fu', 'investigatorAffiliation': 'Renmin Hospital of Wuhan University'}}}}