Novel Listeria Vectors Secreting Gut Flora-Altering Agent... | NCT03014284

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

NCT03014284

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Withdrawn

Last Update Posted

Sep 17, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Colon Cancer
Colitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HSC20160555H	Other Identifier	UTHSCSA IRB

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Military collaborator sample supplier was transferred, no samples obtained

Expanded Access Info

Start Date

Jan 20, 2017Actual

Primary Completion Date

Sep 12, 2018Actual

Completion Date

Sep 12, 2018Actual

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Jan 6, 2017

First Posted Date

Jan 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2018

Last Update Posted Date

Sep 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of B7-H1	To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues	Baseline tissue collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tyler Curiel, MD	University of Texas Health Science Center at the Cancer Therapy and Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Therapy & Research Center at UTHSCSA		San Antonio	Texas	78229	United States

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D003092	Colitis

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided