EndometriosisFEELINGNCT01351051
A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis
An observational study of Endometriosis, run by Ipsen at 7 sites in 3 countries.
Trial summary
This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 1,008 participants
- Where
- 7 sitesin 3 countries
- Study dates
- May 2011to Apr 2013
- 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 to 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.
Who may be able to join
- The subject is a female aged between 18 and 41 years
- The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months
- The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis
- The subject has given a written informed consent prior to any study-related procedures
Who cannot join
- The subject is pregnant
- The subject's surgery results showed evidence of malignancy
- The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
China4 sites
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
The Third Xiangya Hospital of Central South University
Changsha
Women's Hospital School of Medicine, Zhejiang University
Zhejiang
Russia2 sites
Research Institute of Maternity and Childhood named after V.N. Gorodkov
Ivanovo
Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology
Moscow
About this study
Official title: A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis
This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No endometriosis | Not described | |
| Superficial endometriosis | Not described | |
| Endometrioma | Not described | |
| Deep infiltrating endometriosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
Measured: Enrolment visit
Secondary outcomes (3)
Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.
Measured: Enrolment visit
Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.
Measured: Enrolment visit
Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.
Measured: Enrolment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351051
- Sponsor's protocol ID
- A-38-52014-185
- Acronym
- FEELING
- Status last verified
- Jan 2019
- First submitted
- 8 Apr 2011
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dai Y, Zhou Y, Zhang X, Xue M, Sun P, Leng J, Chapron C. Factors associated with deep infiltrating endometriosis versus ovarian endometrioma in China: a subgroup analysis from the FEELING study. BMC Womens Health. 2018 Dec 22;18(1):205. doi: 10.1186/s12905-018-0697-7.
PubMed 30577792Chapron C, Lang JH, Leng JH, Zhou Y, Zhang X, Xue M, Popov A, Romanov V, Maisonobe P, Cabri P. Factors and Regional Differences Associated with Endometriosis: A Multi-Country, Case-Control Study. Adv Ther. 2016 Aug;33(8):1385-407. doi: 10.1007/s12325-016-0366-x. Epub 2016 Jun 24.
PubMed 27342743
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT01351051
- Acronym / sponsor ID
- FEELING / A-38-52014-185
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 May 2011 (estimated)
- 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 will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No endometriosis | – | – |
| Superficial endometriosis | – | – |
| Endometrioma | – | – |
| Deep infiltrating endometriosis | – | – |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.
Key inclusion criteria (4 listed)
- The subject is a female aged between 18 and 41 years
- The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months
- The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis
- The subject has given a written informed consent prior to any study-related procedures
Key exclusion criteria (3 listed)
- The subject is pregnant
- The subject's surgery results showed evidence of malignancy
- The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
Time frame: Enrolment visit
3 secondary outcomes
Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.
Time frame: Enrolment visit
Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.
Time frame: Enrolment visit
Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.
Time frame: Enrolment visit
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 14 Jan 2019.
- Derived from this study: PubMed 30577792Dai Y, Zhou Y, Zhang X, Xue M, Sun P, Leng J, Chapron C. Factors associated with deep infiltrating endometriosis versus ovarian endometrioma in China: a subgroup analysis from the FEELING study. BMC Womens Health. 2018 Dec 22;18(1):205. doi: 10.1186/s12905-018-0697-7.
- Derived from this study: PubMed 27342743Chapron C, Lang JH, Leng JH, Zhou Y, Zhang X, Xue M, Popov A, Romanov V, Maisonobe P, Cabri P. Factors and Regional Differences Associated with Endometriosis: A Multi-Country, Case-Control Study. Adv Ther. 2016 Aug;33(8):1385-407. doi: 10.1007/s12325-016-0366-x. Epub 2016 Jun 24.
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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.
Ipsen Medical Director study director
Ipsen
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Ipsen at 7 sites in 3 countries.
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 4 inclusion and 3 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Russia, France. 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?
Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire. (time frame: Enrolment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351051, which also lists 2 linked publications.
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 14 Jan 2019.