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Not yet recruitingNCT07211230Updated Apr 9, 2026

Collagenase Biobank Study

An observational study in Colorectal (Colon or Rectal) Cancer, sponsored by University of Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by University of Chicago · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
107
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal (Colon or Rectal) Cancer

Keywords

  • colorectal cancers
  • biobank
  • Collagenase Biobank
  • Tissue collection
  • stool collection
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 107 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing Colorectal Surgery

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
107 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07211230
Lead sponsor
University of Chicago
Collaborators
University of California, San Diego, Midwestern University
Responsible party
Sponsor
First posted
Oct 7, 2025
Start date
Aug 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Apr 9, 2026

Study contacts

Benjamin Shogan, MD
Contact
bshogan@bsd.uchicago.edu
(773) 732-2260
Teresa Barry
Contact
tbarry@bsd.uchicago.edu
Benjamin P Shogan
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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