Local Invasion of Pancreatic Cancer
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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 |
|---|
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Pancreatic Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Frequency of Methods of Local Invasion of Pancreatic Adenocarcinoma |
- 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.
- 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.
| Estimated Enrollment: | 900 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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. We 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 will include patients who have been diagnosed with pancreatic adenocarcinoma and who are undergoing surgical resection at CUMC.
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| Contact: Wendy K Chung, MD | wkc15@columbia.edu | |
| Contact: Ashley Dikos | 734-330-9282 | ajd2147@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Wendy K Chung, MD wkc15@columbia.edu | |
| Contact: Ashley Dikos ajd2147@columbia.edu | |
| Principal Investigator: Wendy K Chung, MD | |
| 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: | July 2, 2012 |
| 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:
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Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013