Colon CancerNCT03014284
Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
An observational study of Colon Cancer and Colitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colitis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 12 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent (or have consent provided through a guardian)
- Not having colon material collected as part of standard of care
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
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
- Medical subject headings
- Colonic Neoplasms, Colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of B7-H1
To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues
Measured: Baseline tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start20 Jan 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: Military collaborator sample supplier was transferred, no samples obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler Curiel, MD, Principal investigator, University of Texas Health Science Center at the Cancer Therapy and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014284
- Sponsor's protocol ID
- CTMS 16-0101
- Other IDs
- HSC20160555H
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2016
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
- ClinicalTrials.gov ID
- NCT03014284
- Acronym / sponsor ID
- CTMS 16-0101
- Conditions
- Colon Cancer, Colitis
- Keywords
- Tissue collection, colonoscopic surgical procedures
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Military collaborator sample supplier was transferred, no samples obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent (or have consent provided through a guardian)
- Not having colon material collected as part of standard of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of B7-H1
Time frame: Baseline tissue collection
To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Curiel, MD principal investigator
University of Texas Health Science Center at the Cancer Therapy and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of B7-H1 (time frame: Baseline tissue collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.