Local Invasion of Pancreatic Cancer

This study is currently recruiting participants.
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
  Purpose

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
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 900
Study Start Date: September 2000
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129167

Contacts
Contact: Wendy K Chung, MD 212-851-5313 wkc15@columbia.edu
Contact: Vilma Rosario 212-305-6033 vr2222@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Wendy K Chung, MD    212-851-5313    wkc15@columbia.edu   
Contact: Vilma Rosario    212-305-6033    vr2222@columbia.edu   
Principal Investigator: Wendy K Chung, MD         
Sponsors and Collaborators
Wendy K. Chung
Investigators
Principal Investigator: Wendy K Chung, MD Columbia University
  More Information

No publications provided

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
Study First Received: May 21, 2010
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 21, 2014