HerResolve™ blood test to detect endometriosis in symptomatic women
Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
This will test whether the HerResolve™ non-invasive blood test can detect endometriosis in women aged 18–49 who have pelvic pain or abnormal bleeding and are scheduled for laparoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07006987 on ClinicalTrials.gov |
What this trial studies
HerResolve is a non-invasive blood-based test being tested to detect the presence of endometriosis. Eligible women aged 18–49 with mild to severe pelvic pain and/or abnormal bleeding will have blood drawn during the secretory or proliferative phase of their menstrual cycle prior to diagnostic laparoscopy. Laparoscopy with histologic confirmation serves as the reference standard to determine whether the blood test identifies endometriosis. The trial is conducted at the Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong.
Who should consider this trial
Good fit: Women aged 18–49 who experience pelvic pain and/or abnormal bleeding, are scheduled for diagnostic laparoscopy with histologic sampling, and can provide a menstrual phase–timed blood sample are ideal candidates.
Not a fit: Patients who are pregnant or lactating, have cancer or are receiving chemotherapy/radiotherapy, cannot undergo laparoscopy, are enrolled in other interventional studies, or refuse medical history collection are unlikely to benefit.
Why it matters
Potential benefit: If successful, HerResolve could provide a simple blood test to help diagnose endometriosis earlier and reduce reliance on invasive diagnostic surgery.
How similar studies have performed: Prior research on blood-based biomarkers for endometriosis has produced mixed results and no non-invasive blood test is yet widely accepted, so this approach is promising but still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Department of Obstetrics & Gynaecology The Chinese University of Hong Kong — Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Elaine Ng
- Email: elaineng@cuhk.edu.hk
- Phone: 35052745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.