Collagenase Biobank Study | NCT07211230

Studies
Collagenase Biobank Study

NCT07211230

Sponsor

University of Chicago

Status

Not yet recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

107Estimated

Phase

Not provided

Conditions

Colorectal (Colon or Rectal) Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2026Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Sep 5, 2025

First Submission Date that Met QC Criteria

Sep 29, 2025

First Posted Date

Oct 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 9, 2026Actual

Name	Class
University of California, San Diego	OTHER
Midwestern University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

107Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	From Enrollment to 12 months postoperative.
Stool metabolomics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing Colorectal Surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Shogan, MD	Contact	(773) 732-2260		bshogan@bsd.uchicago.edu
Teresa Barry	Contact			tbarry@bsd.uchicago.edu

Overall Officials

Name	Affiliation	Role
Benjamin P Shogan	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.