Collagenase Biobank Study

NCT07211230 | Not Yet Recruiting

• 1 other identifier: IRB25-0833
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal (Colon or Rectal) Cancer

Keywords

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

Outcome Measures

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.

  From Enrollment to 12 months postoperative.

Secondary Outcomes (3)

• Stool Metagenomics

  From Enrollment to 12 months postoperative.

• Stool metabolomics

  From Enrollment to 12 months postoperative.

• Serum Metabolomics

  From Enrollment to 12 months postoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing Colorectal Surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Midwestern University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected prior to surgery, day of surgery, during hospitalization, 6 months after surgery, and 12 months after surgery. The prior to surgery sample, during surgery, and during hospitalization samples will be collected as part of routine lab draws. Tissue Collection: A surgically resected malignant tumor tissue and adjacent normal tissue sample will be processed and created into organoids by the UChicago Organoid and Primary Culture Research Core (OPCR). Stool collection: For the preoperative and postoperative samples stool will be self-collected with a specimen kit that is provided to each patient at study enrollment. The patient will use this kit to collect and send stool specimens overnight at 4 degrees Celsius to PI Shogan's laboratory. For the inpatient sample, the sample will be collected by the nurse and a member of the research team will bring to the Shogan Lab.

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Benjamin P Shogan

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Shogan, MD

CONTACT

(773) 732-2260; bshogan@bsd.uchicago.edu

Teresa Barry

CONTACT

tbarry@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: October 7, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)