Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT01031056
Status:
WITHDRAWN
Last Update Posted:
2012-05-28
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'This study requires that we obtain archived tumor and normal tissue and blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in research focus', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2099-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-11', 'lastUpdatePostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2099-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'None: Biospecimen will be collected for future research.'}]}, 'conditionsModule': {'conditions': ['Gastrointestinal Neoplasms', 'Gynecologic Cancers', 'Gynecologic Cancers Cervical Cancer', 'Gastric (Stomach) Cancer', 'Gastro-Esophageal(GE) Junction Cancer', 'Gastrointenstinal Stromal Tumor (GIST)', 'Colon/Rectal Cancer', 'Colon/Rectal Cancer Colon Cancer', 'Colon/Rectal Cancer Rectal Cancer', 'Colon/Rectal Cancer Anal Cancer', 'Anal Cancer', 'Hepatobiliary Cancers', 'Hepatobiliary Cancers Liver', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers.\n\nPRIMARY OBJECTIVES:\n\n1\\. To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers.\n\nSECONDARY OBJECTIVES:\n\n1. Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories\n2. Collect details about the tumor specimen extracted from patient charts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gastrointestinal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1. Patients are eligible if they have a histologically proven gastrointestinal cancer (esophageal, gastroesophageal junction, gastric, small intestine, appendix, colon, rectum, anus, liver, gallbladder, bile ducts, pancreas, neuroendocrine, and GI stromal tumor).\n\n2\\. 18 years of age or older\n\n3\\. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:None'}, 'identificationModule': {'nctId': 'NCT01031056', 'briefTitle': 'Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Collection of Biospecimen and Clinical Information in Patients With Gastrointestinal Cancers', 'orgStudyIdInfo': {'id': 'SU-09092009-3840'}, 'secondaryIdInfos': [{'id': 'GI0004'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood Draw', 'type': 'PROCEDURE'}, {'name': 'Frozen Tumor Specimens', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Teri A Longacre M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caring for Carcinoid Foundation', 'class': 'OTHER'}, {'name': 'GI Cancer Research Gift Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}