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Collagenase Biobank Study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07211230
Enrollment
107
Registered
2025-10-07
Start date
2026-08-01
Completion date
2026-10-01
Last updated
2026-04-09

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

Conditions

Colorectal (Colon or Rectal) Cancer

Keywords

colorectal cancers, biobank, Collagenase Biobank, Tissue collection, stool collection

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of Chicago
Lead SponsorOTHER
University of California, San Diego
CollaboratorOTHER
Midwestern University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Collagenase ActivityFrom 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.

Secondary

MeasureTime frameDescription
Stool MetagenomicsFrom 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.
Stool metabolomicsFrom 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.
Serum MetabolomicsFrom Enrollment to 12 months postoperativeAssess 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.

Countries

United States

Contacts

CONTACTBenjamin Shogan, MD
bshogan@bsd.uchicago.edu(773) 732-2260
CONTACTTeresa Barry
tbarry@bsd.uchicago.edu
PRINCIPAL_INVESTIGATORBenjamin P Shogan

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026