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Trial record 21 of 479 for:    colon cancer | ( Map: Texas, United States )

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

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ClinicalTrials.gov Identifier: NCT03014284
Recruitment Status : Withdrawn (Military collaborator sample supplier was transferred, no samples obtained)
First Posted : January 9, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease
Colon Cancer Colitis

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
Actual Study Start Date : January 20, 2017
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : September 12, 2018



Primary Outcome Measures :
  1. Expression of B7-H1 [ Time Frame: Baseline tissue collection ]
    To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014284


Locations
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United States, Texas
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Tyler Curiel, MD University of Texas Health Science Center at the Cancer Therapy and Research Center

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03014284     History of Changes
Other Study ID Numbers: CTMS 16-0101
HSC20160555H ( Other Identifier: UTHSCSA IRB )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: February 2018
Keywords provided by The University of Texas Health Science Center at San Antonio:
Tissue collection
colonoscopic surgical procedures
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Colitis
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis