This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 July 2017 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01416714
First received: August 20, 2010
Last updated: July 24, 2017
Last verified: July 2017
  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 ]
    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 ]
    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 ]
    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
Actual Study Start Date: July 2, 2008
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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: July 24, 2017

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

ClinicalTrials.gov processed this record on September 20, 2017