Endometriosis
Conditions
Brief summary
Endometriosis (EMS) is a common gynecological disease that affects 176 million girls and women globally. EMS affects 5-10% of women and adolescents within the reproductive age range of 15-49 years, and for those facing infertility, this figure may climb up to 50%. EMS can start at the first menstrual period and last until menopause. Shockingly, between 50% and 80% of women grappling with pelvic pain are found to have EMS. The formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body can cause severe pain and lead to infertility.
Interventions
DEVICEA non-invasive blood-based (HerResolve)
A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Females aged 18 to 49 with mild to severe symptoms of pelvic pain and/or abnormal bleeding. * Diagnostic laparoscopy is scheduled with histology on any visually suspected endometriosis, and all reports (surgical and pathology) to confirm a positive result. If no visually suspicious endometriotic lesions are seen, biopsies from random areas during the laparoscopy procedure to confirm a negative histopathology result. * Blood drawn during secretory or proliferative phase of the menstrual cycle * Provide written informed consent to participate in the study and provide medical history on medications.
Exclusion criteria
* Patients who object to medical history collection and data requests * Patients with cancer and/or undergoing chemotherapy and/or radiotherapy * Patients who are unable or do not undergo laparoscopic surgery * Patients participating in additional interventional clinical studies * Pregnant, lactating, or subjects who are not healthy enough for blood donation. * Blood drawn during menses or ovulation phase of menstrual cycle * Females who are post-menopausa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detecting endometriosis as compared to diagnostic laparoscopy | 1 week | To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Objective: | 1 year | Sensitivity: 90% (95% CI: 85%, 98%) Specificity: 90% (95% CI: 85%, 94%) Statistical Analysis will also include PPV and NPV. Sub-group analysis will be performed |
Countries
China
Contacts
Primary ContactElaine Ng
Outcome results
None listed