Clinical trial · Observational
Collagenase Biobank Study
Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal (Colon or Rectal) Cancer | Childhood Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Collagenase Activity
- timeFrame
- From Enrollment to 12 months postoperative.
- description
- 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 (3)
- measure
- Stool Metagenomics
- timeFrame
- From Enrollment to 12 months postoperative.
- description
- 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.
- measure
- Stool metabolomics
- timeFrame
- From Enrollment to 12 months postoperative.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available