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Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01129167
Recruitment Status : Active, not recruiting
First Posted : May 24, 2010
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wendy K. Chung, Columbia University

Brief Summary:
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.

Condition or disease
Pancreatic Cancer

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 1052 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma
Actual Study Start Date : September 15, 2009
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Frequency of local invasion modalities in surgical population [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will include patients who have been diagnosed with pancreatic adenocarcinoma and who are undergoing surgical resection at CUMC.
Criteria

Inclusion Criteria:

  • Tissue confirmed diagnosis of pancreatic adenocarcinoma.
  • Underwent surgical resection for adenocarcinoma at the Columbia University Medical Center between 2001-2009.

Exclusion Criteria:

  • Did not undergo surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129167


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Wendy K Chung, MD Columbia University

Responsible Party: Wendy K. Chung, Assistant Professor of Pediatrics, Molecular Genetics, Columbia University
ClinicalTrials.gov Identifier: NCT01129167     History of Changes
Other Study ID Numbers: AAAD6885
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wendy K. Chung, Columbia University:
Pancreatic adenocarcinoma
Local invasion by pancreatic adenocarcinoma
Recurrence of pancreatic cancer
Surgical resection of pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases