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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Recruitment Status : Withdrawn (Military collaborator sample supplier was transferred, no samples obtained)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

Tracking Information
First Submitted Date December 20, 2016
First Posted Date January 9, 2017
Last Update Posted Date September 17, 2018
Actual Study Start Date January 20, 2017
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2017)
Expression of B7-H1 [ Time Frame: Baseline tissue collection ]
To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03014284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
Official Title Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Obtain human colon tissue for ex vivo studies of B7-H1 expression, signaling pathways and effects of recombinant Listeria vectors.
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.
Condition
  • Colon Cancer
  • Colitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 13, 2018)
0
Original Estimated Enrollment
 (submitted: January 6, 2017)
100
Actual Study Completion Date September 12, 2018
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03014284
Other Study ID Numbers CTMS 16-0101
HSC20160555H ( Other Identifier: UTHSCSA IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor The University of Texas Health Science Center at San Antonio
Collaborators Not Provided
Investigators
Principal Investigator: Tyler Curiel, MD University of Texas Health Science Center at the Cancer Therapy and Research Center
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date February 2018