Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT01129167
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2010-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1052}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2010-05-21', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of local invasion modalities in surgical population', 'timeFrame': '1 year', 'description': 'The clinical and pathology information from the CUMC surgical database will be reviewed to determine the frequency of the various modalities of local invasion of pancreatic adenocarcinoma. This includes: peripancreatic fat invasion, neural/perineural invasion, vascular invasion, macrovascular invasion, duodenal invasion, bile duct invasion, splenic invasion,and gastric invasion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic adenocarcinoma', 'Local invasion by pancreatic adenocarcinoma', 'Recurrence of pancreatic cancer', 'Surgical resection of pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer often spreads through local invasion into local structures, including fat, blood vessels, nerves, and nearby organs (stomach, duodenum, spleen, bile duct). Local microscopic invasion is associated with recurrence of pancreatic cancer after pancreatic resection, such that even if the original cancer is surgically removed, microscopic areas of cancer often remain. Data on the patterns of local invasion by pancreatic cancer have not been published. In this study, The investigators hope to investigate the frequency of the various methods of local invasion of pancreatic adenocarcinoma. This would help the investigators better understand how pancreatic cancer spreads, and determine what cancers are not resectable.', 'detailedDescription': 'Pancreatic cancer is the eighth most common malignancy, and the fifth leading cause of cancer-related death, in the United States. Unfortunately, patients often present late in the course of the disease. Accordingly, the 1- year survival rate is approximately 20%, and the 5-year survival rate is less than 4%. Even in patients with local disease who are surgical candidates, survival at five years remains only 10-25%. Staging for pancreatic adenocarcinoma typically utilizes the TNM classification, where "T" represents tumor size, "N" represents regional lymph node metastasis, and "M" represents distant metastasis. This type of staging can usually only be done after operative resection. Unfortunately, up to 25% of patients are found to be unresectable at the time of surgical exploration. This is most often due to local invasion or metastatic disease. Local microscopic invasion is associated with recurrence of pancreatic cancer after pancreatic resection. Comprehensive data on the patterns of local invasion by pancreatic cancer have not been published. The investigators believe that it would be beneficial to investigate the frequency of the various methods of local invasion of pancreatic adenocarcinoma. A clearer understanding of the natural history of local invasion could potentially lead to a better determination of what constitutes unresectability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will include patients who have been diagnosed with pancreatic adenocarcinoma and who are undergoing surgical resection at CUMC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tissue confirmed diagnosis of pancreatic adenocarcinoma.\n* Underwent surgical resection for adenocarcinoma at the Columbia University Medical Center between 2001-2009.\n\nExclusion Criteria:\n\n* Did not undergo surgery.'}, 'identificationModule': {'nctId': 'NCT01129167', 'briefTitle': 'Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AAAD6885'}}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Wendy K Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}