The Asymmetry Distribution of Endometriotic Lesions: Italian Multicenter Study (NICCHIENDO)

December 12, 2025 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

The Asymmetry of Endometriotic Lesions as Demonstration of the Theory of Menstrual Reflux and Anatomical Niches: Italian Multicenter Study by the ETIC Group

This study aims to understand whether endometriosis lesions - and tumors that can arise in association with endometriosis - occur more often on one side of the pelvis than the other.

During surgery, doctors will record the exact location of each lesion to see if there is a consistent right- or left-sided pattern.

Understanding these patterns may help improve knowledge about how endometriosis develops (pathogenesis), and thus improve its treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Gynecology Unit, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with histological diagnosis of endometriosis and endometriosis associated with endometrioid carcinoma, clear cell carcinoma and seromucinous borderline tumor operated at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and at the centers participating in the study from 01/2013 to 12/2023 will be recruited.

Data relating to histological diagnosis will be collected from medical records.

In particular, in addition to tumours associated with endometriosis, data will be collected from patients with a histological diagnosis of:

  1. ovarian endometriosis
  2. intestinal endometriosis
  3. ureteral endometriosis
  4. sciatic nerve endometriosis
  5. inguinal-round ligament endometriosis
  6. uterosacral ligament endometriosis
  7. peritoneal endometriosis
  8. diaphragmatic endometriosis
  9. pleural and pulmonary endometriosis
  10. umbilical endometriosis (associated with right hemidiaphragm and/or left hemidiaphragm)

Description

Inclusion Criteria:

  • age ≥18 years at the time of histological diagnosis of endometriosis
  • patients undergoing surgery with endometriotic lesions or patients with endometriotic lesions associated with endometrioid or clear cell ovarian cancer (Stage I-II) or borderline seromucinous ovarian cancer
  • first operation for endometriosis in the reference center (if recurrence consider only if both operations were performed at the reference center).

Exclusion Criteria:

  • age <18 years
  • patients affected by Stage I-II endometrioid or clear cell carcinoma or seromucinous borderline ovarian cancer not associated with endometriosis or in a more advanced stage of disease
  • women with an ultrasound diagnosis of endometriosis who have not undergone surgery
  • previous operations for endometriosis performed at another center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asymmetric distribution of endometriotic lesions on paired pelvic organs
Time Frame: At the time of index surgery

Proportion of patients presenting an asymmetric (right- or left-sided) distribution of endometriotic lesions on even and symmetrical pelvic organs (e.g., ovaries, uterosacral ligaments), based on the laterality observed and described during the index surgical procedure.

Side-specific frequencies (right vs left) will be reported as number and percentage.
At the time of index surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asymmetric distribution of malignant ovarian lesions related to endometriosis
Time Frame: At the time of index surgery

Proportion of patients presenting an asymmetric (right- or left-sided) distribution of malignant lesions related to endometriosis-specifically endometrioid ovarian carcinoma, clear cell ovarian carcinoma, and seromucinous borderline tumors-based on the laterality observed and described during the index surgical procedure.

Side-specific frequencies (right vs left) will be reported as number and percentage.
At the time of index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0029787 U
  • NICCHIENDO (Other Identifier: IRCCS Fondazione Ca' Granda, Ospedale Maggiore, Policlinico, Milan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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