A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis (FEELING)
This study is currently recruiting participants.
Verified March 2013 by Ipsen
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01351051
First received: April 8, 2011
Last updated: March 31, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Endometriosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
- Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
- Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1008 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| No endometriosis |
| Superficial endometriosis |
| Endometrioma |
| Deep infiltrating endometriosis |
Eligibility| Ages Eligible for Study: | 18 Years to 41 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351051
Contacts
| Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
Locations
| China | |
| Peking Union Medical College Hospital | Active, not recruiting |
| Beijing, China | |
| Peking University First Hospital | Active, not recruiting |
| Beijing, China | |
| The Third Xiangya Hospital of Central South University | Active, not recruiting |
| Changsha, China | |
| Women's Hospital School of Medicine, Zhejiang University | Active, not recruiting |
| Zhejiang, China | |
| France | |
| Hôpital St Vincent de Paul | Recruiting |
| Paris, France | |
| Russian Federation | |
| Research Institute of Maternity and Childhood named after V.N. Gorodkov | Recruiting |
| Ivanovo, Russian Federation | |
| Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology | Recruiting |
| Moscow, Russian Federation | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Patrick Cabri, M.D. | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01351051 History of Changes |
| Other Study ID Numbers: | A-38-52014-185 |
| Study First Received: | April 8, 2011 |
| Last Updated: | March 31, 2013 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: The Commission nationale de l’informatique et des libertés Russia: Ethics Committee China: Ethics Committee |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013