Official Title

HerResolve Clinical Performance Study

Purpose

The primary objective of this case-control prospective study is to evaluate the clinical (diagnostic) performance of HerResolve (a molecular test composed of a miRNA-specific panel designed for quantitative PCR and bioinformatics analysis) as a reliable non-invasive diagnostic test for endometriosis using blood plasma and serum

Detailed Description

Endometriosis is an estrogen-dependent chronic inflammatory condition that affects approximately 10-15% of women of reproductive age and 20-50% of infertile women worldwide. The disease is defined as a disorder in which tissues resembling the endometrium grow outside the uterine cavity affecting the pelvic tissues. There remain significant challenges to diagnosing endometriosis. The clinical presentation varies widely, from asymptomatic to severe, and no diagnostic biomarkers have been approved to date for the routine reliable clinical diagnosis of endometriosis. Diagnostic imaging tests such as pelvic ultrasound and magnetic resonance imaging are used to diagnose endometriosis, especially deep endometriosis. However, the examiner’s expertise has a great influence on the imaging findings, ultimately making diagnosis challenging. In the absence of positive imaging findings, the final diagnosis of superficial endometriosis can only be made by histological analysis of the lesion site, which is usually obtained by surgery. miRNAs are small endogenous noncoding RNA (ribonucleic acid) molecules involved in the posttranscriptional regulation of gene expression. Given that these small molecules can be easily accessed from bodily fluids, they are the focus of many studies investigating their role as potential diagnostic biomarkers for endometriosis. In fact, reports of miRNAs found in different body fluids, such as blood serum and plasma, vaginal fluid, urine, and saliva suggested diagnostic potential. In this prospective case-control study, our selection of endometriosis miRNA biomarkers is based on the following criteria: 1) miRNAs that have been extensively studied and described in in genomic databases (bioinformatics pipeline construction); 2) miRNAs with demonstrated differential expression between patient and controls; 3) can be detected in serum and/or plasma; and 4) reproducible differential expression between patient plasma or serum to matched endometriotic lesions has been shown. Based on these points, we selected a proprietary panel of five miRNAs to determine the presence or absence of endometriosis using a blood sample (HerResolve). Primary Objective: To evaluate the clinical (diagnostic) performance of HerResolve (a molecular test composed of a miRNA-specific panel designed for quantitative PCR and bioinformatics analysis) as a reliable non-invasive diagnostic test for endometriosis using blood plasma and serum. This study is a case-control, multi-center, prospective, observational study intended to determine the clinical performance of HerResolve to accurately detect endometriosis as based on histology. The study will include collection of blood samples from women experiencing symptoms and suspected to have endometriosis. Women previously histologically confirmed to have endometriosis and continuing to exhibit symptoms 6 months post-surgery, can also be enrolled. Subjects will be classified as positive or negative for endometriosis based on histology. Samples of blood will be collected prior to surgery (sampling should be done before administration of any drugs to exclude the effect of the drug on the sample). Two tubes of 8-10 ml of blood each will be collected from each patient for plasma and serum. Blood samples are collected during the secretory phase of the menstrual cycle when possible. Plasma and serum are recovered within 2 hours of blood draw, processed (centrifugation) and then frozen to -80C or lower for storage and transport to the Heranova laboratory for HerResolve testing (RNA isolation, cDNA preparation and miRNA pane qPCR analysis).

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 49 years old;

2. Patient signed the study's informed consent form;

3. Patient presents with infertility, abdominal pain, chronic pelvic pain, or abnormal bleeding symptoms ;

4. Sampling is performed during the secretory phase of the menstrual cycle;

5. Patient has (histologically confirmed) or is suspected of endometriosis requiring surgery with surgery scheduled;

6. Patient is not on Hormone (e.g. GnRH) suppression therapy (washout of 4 weeks). Oral contraceptives do not need washout period.;

7. Has not taken antibiotic within 7 days prior to surgery.

Exclusion Criteria

1. Age < 18 or >49;

2. Pregnant women ;

3. Patients infected with acquired immunodeficiency virus (HIV) or other viral pathogens/STDs;

4. Failure to comply with study protocols ;

5. Patients who object to medical history collection and data requests;

6. Patients undergoing chemotherapy and/or radiotherapy (withdrawal period is 4 weeks).;

7. Patients who do not show any symptoms and/or are unable to undergo surgery;

8. Patients participating in additional interventional clinical studies;

9. Antibiotics used within 7 days of surgery

Keywords and/or Specific Medical Conditions

Endometriosis

Obstetrics and Gynecology

Sponsors

Heranova Lifesciences