Local Invasion of Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Wendy K. Chung, Columbia University
ClinicalTrials.gov Identifier:
NCT01129167
First received: May 21, 2010
Last updated: February 19, 2014
Last verified: February 2014

May 21, 2010
February 19, 2014
September 2000
December 2014   (final data collection date for primary outcome measure)
Frequency of local invasion modalities in surgical population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
We will review the clinical and pathology information from the CUMC surgical database 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.
Primary outcome: Frequency of local invasion modalities in surgical population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
We will review the clinical and pathology information from the CUMC surgical database 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.
Complete list of historical versions of study NCT01129167 on ClinicalTrials.gov Archive Site
Understanding the natural history of local invasion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
We will also record several characteristics of the tumor, preoperative treatment, and surgical course including: neoadjuvant chemotherapy, histology, type of surgery, margins, and number of lymph nodes dissected. In addition, we will also record several demographic parameters, including, age, age at surgery, race, gender, tobacco history, family history, and pre-operative imaging. Understanding the natural history of local invasion could potentially lead to a better determination of what constitutes unresectability, as well as the frequency of recurrence.
Secondary Outcome: Understanding the natural history of local invasion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
We will also record several characteristics of the tumor, preoperative treatment, and surgical course including: neoadjuvant chemotherapy, histology, type of surgery, margins, and number of lymph nodes dissected. In addition, we will also record several demographic parameters, including, age, age at surgery, race, gender, tobacco history, family history, and pre-operative imaging. Understanding the natural history of local invasion could potentially lead to a better determination of what constitutes unresectability, as well as the frequency of recurrence.
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Local Invasion of Pancreatic Cancer
Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Study population will include patients who have been diagnosed with pancreatic adenocarcinoma and who are undergoing surgical resection at CUMC.

Pancreatic Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Wendy K Chung, MD 212-851-5313 wkc15@columbia.edu
Contact: Vilma Rosario 212-305-6033 vr2222@columbia.edu
United States
 
NCT01129167
AAAD6885
Yes
Wendy K. Chung, Columbia University
Wendy K. Chung
Not Provided
Principal Investigator: Wendy K Chung, MD Columbia University
Columbia University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP