Colorectal (Colon or Rectal) CancerNCT07211230
Collagenase Biobank Study
An observational study of Colorectal (Colon or Rectal) Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing Colorectal Surgery
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Teresa Barry contact
United States1 site
University of Chicago
Chicago, Illinois, 60637
Teresa Barry, 773-702-5681, tbarry@bsd.uchicago.edu
cdixon520@bsd.uchicago.edu
About this study
Official title: Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery
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.
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Keywords
- colorectal cancers, biobank, Collagenase Biobank, Tissue collection, stool collection
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Enrollment to 12 months postoperative.
Secondary outcomes (3)
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.
Measured: From Enrollment to 12 months postoperative.
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.
Measured: From Enrollment to 12 months postoperative.
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.
Measured: From Enrollment to 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Midwestern University
- Responsible party
- Sponsor
- Investigators
- Benjamin P Shogan, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211230
- Sponsor's protocol ID
- IRB25-0833
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery
- ClinicalTrials.gov ID
- NCT07211230
- Acronym / sponsor ID
- IRB25-0833
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Keywords
- colorectal cancers, biobank, Collagenase Biobank, Tissue collection, stool collection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of California, San Diego, Midwestern University
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing Colorectal Surgery
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Stool Metagenomics
Time frame: From Enrollment to 12 months postoperative.
Stool metabolomics
Time frame: From Enrollment to 12 months postoperative.
Serum Metabolomics
Time frame: From Enrollment to 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa Barry contact
Benjamin P Shogan principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal (Colon or Rectal) Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Shogan, MD ((773) 732-2260, bshogan@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagenase Activity (time frame: From Enrollment to 12 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.