NCT07386431

Brief Summary

The goal of this study is to identify the molecular or genetic mechanisms that may predispose patients with bowel endometriosis to an increased risk of colorectal carcinoma. The study will include patients for whom surgical treatment of bowel endometriosis is clinically indicated. This research would represent a significant advancement in evaluating the necessity of surgical intervention in asymptomatic patients or those with mild symptoms. Furthermore, it would provide a broader insight into the systemic impact of endometriosis on other organ systems, ultimately improving risk assessment and preventive measures.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
37mo left

Started Feb 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026May 2029

First Submitted

Initial submission to the registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

February 6, 2026

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

January 26, 2026

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of gene expression in healthy and with endometriosis affected bowel.

    3 years

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis is a disease that most commonly affects women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients aged 18 and over, treated at the Department of Reproduction for diagnosed deep endometriosis, including bowel endometriosis, for whom surgical treatment is indicated.

You may qualify if:

  • Female patients aged 18 and over, treated at the Department of Reproduction for diagnosed deep endometriosis, including bowel endometriosis, for whom surgical treatment is indicated.

You may not qualify if:

  • Patients with known inflammatory bowel disease (IBD), patients with a personal history of gynecological or gastrointestinal malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy of the bowel with endometriotic nodule and healthy part of bowel

MeSH Terms

Conditions

EndometriosisColorectal NeoplasmsCarcinogenesisInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rok Struna, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

February 6, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share