Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-28 @ 11:02 PM
Study NCT ID:
NCT01675258
Status:
UNKNOWN
Last Update Posted:
2012-08-29
First Post:
2012-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2012-08-27', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Colorectal Cancer and Pre-cancer Polyps', 'Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '19931263', 'type': 'RESULT', 'citation': 'Zhang L, Farrell JJ, Zhou H, Elashoff D, Akin D, Park NH, Chia D, Wong DT. Salivary transcriptomic biomarkers for detection of resectable pancreatic cancer. Gastroenterology. 2010 Mar;138(3):949-57.e1-7. doi: 10.1053/j.gastro.2009.11.010. Epub 2009 Nov 18.'}]}, 'descriptionModule': {'briefSummary': "Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.\n\nOral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.\n\nThe aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients identified with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has not yet started treatment for the identified cancer\n\nExclusion Criteria:\n\n* medically compromised patients\n* congenital syndromes\n* being treated with radiotherapy or chemotherapy.'}, 'identificationModule': {'nctId': 'NCT01675258', 'briefTitle': 'Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'LSA003-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Healthy adults above the age of 18 years', 'interventionNames': ['Other: Salivary samples']}, {'label': 'Study', 'description': 'Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer', 'interventionNames': ['Other: Salivary samples']}], 'interventions': [{'name': 'Salivary samples', 'type': 'OTHER', 'otherNames': ['Salivary Analysis'], 'description': 'Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.', 'armGroupLabels': ['Control', 'Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '0097226777572'}, {'name': 'Moti Moskovitz, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Moti Moskovitz, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'Eyal Shtayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'Avi Levin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}