Health TrialsbyHealthPanel

Collagenase Biobank Study

ConditionColorectal (Colon or Rectal) Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

The purpose of this study is to look at how bacteria present within the stool at the time of surgery and postoperatively may contribute to the development of cancer recurrence after surgery. By collecting stool and blood before and after surgery, the researchers hope to determine if certain types of bacteria, or products that the bacteria produce, promote the development of tumors after surgery. By collecting tumor tissue and growing cell lines, we hope this will help researchers better understand the behavior of these types of tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking.

All genders, races, and ethnicities.

Aged greater or equal to 18 years of age.

Ability to understand and the willingness to sign a written informed consent form.

Disqualifiers

Stage IV colon adenocarcinoma (known metastatic disease).

Intravenous or oral antibiotic exposure within 30 days of surgery to treat an infection.

Prebiotic exposure within 30 days of surgery.

History of neoadjuvant chemotherapy/radiation to treat the primary colon adenocarcinoma.

Trial population

patients undergoing Colorectal Surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Collagenase Activity

Measure collagenase activity present within the stool at the time of surgery to determine if it will be significantly higher in patients who later develop recurrence compared to patients who do not. Assessing further if patients who are the most nutritionally at risk for the development of recurrence will have the highest amounts of bacterial collagenase.

Time frame
From Enrollment to 12 months postoperative.

Secondary outcomes

1

Stool Metagenomics

Assess the correlation of the bacterial community with nutritional intake and the development of colorectal cancer recurrence. Bacterial community analysis will be performed via shotgun metagenomics.

Time frame
From Enrollment to 12 months postoperative.
2

Stool metabolomics

Assess the correlation of the bacterial derived metabolites with nutritional intake and the development of colorectal cancer recurrence. Bacterial community analysis will be performed via short chain fatty acid metabolomics.

Time frame
From Enrollment to 12 months postoperative.
3

Serum Metabolomics

Assess the correlation of the bacterial derived metabolites with nutritional intake and the development of colorectal cancer recurrence. Bacterial community analysis will be performed via short chain fatty acid metabolomics.

Time frame
From Enrollment to 12 months postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

University of California, San Diego

Collaborator

Midwestern University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: