Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis

NCT03014284 | Withdrawn

• 2 other identifiers: CTMS 16-0101HSC20160555H
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a simple tissue collection study with no therapeutic intent. Colon tissues will be taken from standard of care procedures. Tissues will be tested for their functions, expression of immune co-signaling molecules and reactions to transduction with recombinant Listeria vectors to assess effects on expression of B7-H1 and cytokines.

Conditions

Colon Cancer; Colitis

Keywords

Tissue collection; colonoscopic surgical procedures

Outcome Measures

Primary Outcomes (1)

• Expression of B7-H1

  To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues

  Baseline tissue collection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 50% of patients are expected to be Caucasian, about 40% Hispanic and the remainder African American and other minorities. The investigators anticipate that subjects will range in age from 18 years old and older.

You may qualify if:

• Able to provide informed consent (or have consent provided through a guardian)
• No immune-modulating drug use during study or within 30 days prior to enrollment
• Having colon material collected as part of standard of care

You may not qualify if:

• Unable to provide informed consent (or have consent provided through a guardian)
• Not having colon material collected as part of standard of care

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Obtain human colon tissue for ex vivo studies of B7-H1 expression, signaling pathways and effects of recombinant Listeria vectors.

MeSH Terms

Conditions

Colonic Neoplasms; Colitis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis

Study Officials

• Tyler Curiel, MD

  University of Texas Health Science Center at the Cancer Therapy and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 9, 2017
• Study Start: January 20, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-02

Locations

US (1)