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
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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 |
- 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.
- 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 |
Any patient having a biopsy or having surgery
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| Contact: Daniel Catenacci, MD | 773-702-7596 | dcatenac@medicine.bsd.uchicago.edu |
| Contact: Hedy Kindler, MD | 773-702-0360 | hkindler@medicine.bsd.uchicago.edu |
| 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 | |
| Principal Investigator: | Daniel Catenacci, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | dcatenac, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01416714 History of Changes |
| Other Study ID Numbers: | 16294A |
| Study First Received: | August 20, 2010 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anus Neoplasms Colorectal Neoplasms Esophageal Neoplasms Liver Neoplasms Carcinoma, Hepatocellular Stomach Neoplasms Mesothelioma Pancreatic Neoplasms Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Rectal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Colonic Diseases Head and Neck Neoplasms Esophageal Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Stomach Diseases Adenoma |
ClinicalTrials.gov processed this record on May 19, 2013