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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03014284

Enrollment

Registered

2017-01-09

Start date

2017-01-20

Completion date

2018-09-12

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Colon Cancer

Keywords

Tissue collection, colonoscopic surgical procedures

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results