NCT01416714

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2008Jan 2030

Study Start

First participant enrolled

July 2, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

21.5 years

First QC Date

August 20, 2010

Last Update Submit

September 29, 2025

Conditions

Gastric Cancers

Outcome Measures

Primary Outcomes (2)

  • Collect and store blood samples

    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.

    1 year

  • create a database for the collected tissue

    To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols.

    1 year

Secondary Outcomes (1)

  • To create tissue microarrays for each gastrointestinal cancer subtype

    1 year

Study Arms (10)

Gastric Cancer

Gastrointestinal Stromal Tumors (GIST)

Esophageal Cancer

Pancreas Cancer

Hepatocellular Cancer

Biliary Cancer

Neuroendocrine Cancer

Peritoneal Mesothelioma

Anal Cancer

Colorectal Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient having a biopsy or having surgery

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, tissue, DNA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Daniel Catenacci, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Catenacci, MD

CONTACT

773-702-7596dcatenac@medicine.bsd.uchicago.edu

Hedy Kindler, MD

CONTACT

773-702-0360hkindler@medicine.bsd.uchicago.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 15, 2011

Study Start

July 2, 2008

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

US(1)