A Study of Endometriosis Biomarkers
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-000426
NCT ID: NCT03376451
Sponsor Protocol Number: 2017-A01445-48
About this study
The purpose of this study is to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls). EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Endometriosis Patients
- Woman, 18 to 45 years old.
- Patients with endometriosis suspicion, associated adenomyosis is accepted.
- Freely signature of the consent form.
- Patient needs laparoscopy for endometriosis purpose (first intervention or recurrence) regardless of the endometriosis type (superficial, ovarian or deep).
- Possibility of follow up during 2 years.
Healthy Voluntary Patients
- Woman, 18 to 45 years old.
- Freely signature of the consent form.
- Patient needs laparoscopy for another indication than endometriosis, adenomyosis, uterine fibroma & other fibroid pathologies (ex of surgeries: tubular sterilization, ovarian non-fibroid cyst, urinary incontinence requiring ureteral intervention).
Exclusion Criteria:
Endometriosis Patients
- Refusal or linguistic or psychic incapacity to sign informed consent.
- No internet access or refusal to use new technologies.
- Minor woman (under 18 years old).
- Pregnancy or breastfeeding.
- Menopause.
- Evidence of adenomyosis without endometriosis.
- All metabolic pathology, endocrine, chronical infectious or malignant.
- Endometriosis negative result at visual and histological examination by anatomopathologist of the clinical centre.
Healthy Voluntary Patients
- Refusal or linguistic or psychic incapacity to sign informed consent.
- No internet access or refusal to use new technologies.
- Minor woman (under 18 years old).
- Pregnancy or breastfeeding.
- Menopause.
- Adenomyosis.
- All metabolic pathology, endocrine, chronical infectious or malignant.
- Endometriosis positive result at visual and histological examination by anatomopathologist of the clinical centre.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Paul Magtibay, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available