Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01416714
First received: August 20, 2010
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Condition
Gastric Cancers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Collect and store blood samples [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer.

  • create a database for the collected tissue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols.


Secondary Outcome Measures:
  • To create tissue microarrays for each gastrointestinal cancer subtype [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To create tissue microarrays for each gastrointestinal cancer subtype, and to facilitate future molecular studies. To grant access to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, etc., and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples.


Biospecimen Retention:   Samples With DNA

blood, tissue, DNA


Estimated Enrollment: 1000
Study Start Date: June 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric Cancer
Gastrointestinal Stromal Tumors (GIST)
Esophageal Cancer
Pancreas Cancer
Hepatocellular Cancer
Biliary Cancer
Neuroendocrine Cancer
Peritoneal Mesothelioma
Anal Cancer
Colorectal Cancer

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient having a biopsy or having surgery

Criteria

Inclusion Criteria:

  • any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416714

Contacts
Contact: Daniel Catenacci, MD 773-702-7596 dcatenac@medicine.bsd.uchicago.edu
Contact: Hedy Kindler, MD 773-702-0360 hkindler@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Daniel Catenacci, MD    773-702-7596    dcatenac@medicine.bsd.uchicago.edu   
Principal Investigator: Daniel Catenacci, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Daniel Catenacci, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01416714     History of Changes
Other Study ID Numbers: 16294A
Study First Received: August 20, 2010
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Liver Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Pancreatic Neoplasms
Stomach Neoplasms
Adenoma
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Rectal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 22, 2014