Collagenase Biobank Study

April 7, 2026 updated by: University of Chicago

Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The purpose of this study is to collect stool, blood, and tissue samples both before and after patients undergo surgery for colon cancer. These samples will be analyzed for their bacterial composition and function, and assayed for bacterial-derived metabolites. Additionally, these samples will be tested in the laboratory for their ability to promote tumor formation in cancer cells and in animal models of surgery. Finally, patients will undergo nutritional surveys to document their current nutritional intake. Integration of the patient's nutritional intake with the data from the analyzed biospecimens will allow the researchers to determine if these bacteria and/or their metabolites are more prevalent in patients who eat certain diets. Taken together, results from this study will provide knowledge as to the mechanisms by which tumors form after surgery and potentially allow for future therapies to prevent it.

Study Type

Observational

Enrollment (Estimated)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing Colorectal Surgery

Description

Inclusion Criteria:

  • 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.
  • Diagnosed with a colon adenocarcinoma or presumed adenocarcinoma in which surgical resection is recommended.
  • Have a planned surgical resection of the colon adenocarcinoma at the University of Chicago Comprehensive Cancer Center.
  • Reside within 150 miles of the University of Chicago Comprehensive Cancer Center.

Exclusion Criteria:

  • 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.
  • History of chemotherapy/radiation to treat a separate malignancy within the last 6 months.
  • History or current ileostomy or colostomy.
  • Allergy to perioperative medications (oral neomycin/metronidazole for preoperative bowel preparation, intraoperative prophylactic intravenous cefoxitin).
  • Patients who are pregnant.
  • Patients with a history of inflammatory bowel disease.
  • Patients with a history of bariatric surgery.
  • History of eating disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collagenase Activity
Time Frame: From Enrollment to 12 months postoperative.
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.
From Enrollment to 12 months postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Metagenomics
Time Frame: From Enrollment to 12 months postoperative.
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.
From Enrollment to 12 months postoperative.
Stool metabolomics
Time Frame: From Enrollment to 12 months postoperative.
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.
From Enrollment to 12 months postoperative.
Serum Metabolomics
Time Frame: From Enrollment to 12 months postoperative
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.
From Enrollment to 12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

University of California, San Diego
Midwestern University

Investigators

  • Principal Investigator: Benjamin P Shogan, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

September 29, 2025

First Posted (Actual)

October 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-0833

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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