Analyze the Laterality of Endometriotic Lesions and Endometriosis-related TumorsNICCHIENDONCT07304245
The Asymmetry Distribution of Endometriotic Lesions: Italian Multicenter Study
An observational study of Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors and Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors, Endometriosis
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Gynecology Unit, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan
Milan, 20122
About this study
Official title: 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.
- Conditions
- Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors, Endometriosis
- Being tested
- surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
All patients enrolled in the study underwent surgery for endometriosis between 2013 and 2023.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetric distribution of endometriotic lesions on paired pelvic organs
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.
Measured: At the time of index surgery
Secondary outcomes (1)
Asymmetric distribution of malignant ovarian lesions related to endometriosis
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.
Measured: At the time of index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Sep 2024
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analyze the Laterality of Endometriotic Lesions and Endometriosis-related TumorsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304245
- Sponsor's protocol ID
- 0029787 U
- Other IDs
- NICCHIENDO
- Acronym
- NICCHIENDO
- Status last verified
- Oct 2025
- First submitted
- 19 Aug 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Asymmetry of Endometriotic Lesions as Demonstration of the Theory of Menstrual Reflux and Anatomical Niches: Italian Multicenter Study by the ETIC Group
- ClinicalTrials.gov ID
- NCT07304245
- Acronym / sponsor ID
- NICCHIENDO / 0029787 U
- Conditions
- Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors, Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 26 Dec 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryAll patients enrolled in the study underwent surgery for endometriosis between 2013 and 2023. | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Asymmetric distribution of malignant ovarian lesions related to endometriosis
Time frame: At the time of index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Analyze the Laterality of Endometriotic Lesions and Endometriosis-related Tumors and Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Dec 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetric distribution of endometriotic lesions on paired pelvic organs (time frame: At the time of index surgery). 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 26 Dec 2025.