The Association Between Deep Endometriosis and the Occurr... | NCT07386431

Studies
The Association Between Deep Endometriosis and the Occurrence of Colorectal Carcinoma

NCT07386431

Sponsor

University Medical Centre Ljubljana

Status

Not yet recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Endometriosis
Deep Endometriosis
Bowel Endometriosis
Colorectal Carcinoma
Colon Resection
Endometriosis Pelvic
Endometriosis Rectum
Carcinogenesis
Genetic Change
Infertility

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Jun 2025

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

Feb 2026Estimated

Primary Completion Date

Oct 2028Estimated

Completion Date

May 2029Estimated

First Submitted Date

Jan 26, 2026

First Submission Date that Met QC Criteria

Jan 26, 2026

First Posted Date

Feb 4, 2026Actual

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

Feb 5, 2026

Last Update Posted Date

Feb 6, 2026Actual

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 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.

Detailed Description

Not provided

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of gene expression in healthy and with endometriosis affected bowel.		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Endometriosis is a disease that most commonly affects women.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rok Struna, MD	Contact	+38631441111		rok.struna@kclj.si

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D004715	Endometriosis
D015179	Colorectal Neoplasms
D063646	Carcinogenesis
D007246	Infertility

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms