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NCT Number: NCT07211230

Collagenase Biobank Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Shogan, MD

CONTACT

[email protected]

(773) 732-2260

Teresa Barry

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Midwestern University
  • University of California, San Diego

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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