Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01623258
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2012-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '22871988', 'type': 'DERIVED', 'citation': 'Nissan A, Protic M, Bilchik AJ, Howard RS, Peoples GE, Stojadinovic A. United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer. Ann Surg. 2012 Sep;256(3):412-27. doi: 10.1097/SLA.0b013e31826571c8.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.\n\nNull hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 150 male or female military healthcare beneficiaries over the age of 18 years presenting at the Walter Reed Army Medical Center (WRAMC) General Surgery clinic with the diagnosis of biopsy-proven, primary, non-metastatic (Clinical Stage I,II or III) colon carcinoma will be enrolled. Subjects with colonic masses clinically consistent with colon cancer, and eventually confirmed by pathology, will also be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age\n2. Primary, non-metastatic \\[Stage I, II (localized, node negative), or III (localized, node positive)\\] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology\n3. Palpable mass at time of surgery\n4. Capable of providing informed consent\n\nExclusion Criteria:\n\n1. Prior radiation or chemotherapy\n2. Non-palpable colon tumor\n3. Recurrent or Stage IV (metastatic) colon cancer\n4. Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01623258', 'briefTitle': 'A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma', 'organization': {'class': 'FED', 'fullName': 'Walter Reed Army Medical Center'}, 'orgStudyIdInfo': {'id': '03-20010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care', 'description': 'Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging'}, {'label': 'Research', 'description': 'SOC with sentinel lymph node analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20307-5001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Alexander Stojadinovic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Surgical Oncology', 'investigatorFullName': 'Alexander Stojadinovic', 'investigatorAffiliation': 'Walter Reed Army Medical Center'}}}}