Research OutSmarts Endometriosis II Study (ROSE2)

August 31, 2023 updated by: Peter Gregersen, Northwell Health

ROSE II: Pilot Study to Analyze Menstrual Blood to Predict Endometriosis

This product will be used as a diagnostic test to screen for the likelihood of endometriosis in menstruating adults with symptoms suggestive of endometriosis. The purpose of the test will be to guide clinical decisions regarding: 1) whether to undergo diagnostic laparoscopy to confirm the presence of endometriosis (currently, the gold standard for diagnosing endometriosis) and/or 2) how to guide the choice of hormonal or other therapies to treat symptoms of endometriosis.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic, complex, and common gynecologic disorder characterized by the growth of endometrial-like tissues outside of the uterus that is accompanied by inflammation. One of the most frustrating problems for those with endometriosis is the long delay before being diagnosed, which can be up to 7-10 years. One of the reasons for this delay is that definitive diagnosis requires invasive surgery (Tomassetti et al, 2021 PMID: 34690084). There are no approved non-invasive methods for predicting endometriosis. This study will assess the analysis of fresh menstrual blood as a non-invasive predictor of endometriosis. This approach is based on the numerous reports documenting the differences in the endometrium of women with and without endometriosis; this endometrium is shed each month as menstrual blood which can be easily collected and analyzed. Through this prospective, non-interventional pilot study the investigators propose to collect and analyze menstrual blood from healthy controls without chronic symptoms of endometriosis and symptomatic women who have significant and chronic symptoms suggestive of endometriosis and are considered by their healthcare providers to be candidates for diagnostic laparoscopic surgery in the coming months (as part of their standard care). Menstrual blood from controls and symptomatic cases will be analyzed using single cell RNA-sequencing to develop a panel of biomarkers that can be developed into a screening test or diagnostic test for endometriosis.

The primary objectives of this study are to confirm the results of our recent single cell RNA sequencing (scRNA-Seq) analysis of menstrual effluent obtained from healthy controls vs. endometriosis (and symptomatic subjects) obtained through IRB 13-376 and to develop a screening/ diagnostic algorithm (menstrual global (MG) score) based on the data to be used to predict endometriosis in symptomatic patients.

The secondary objective is to assess the reproducibility of the scRNA-Sequencing data using menstrual blood collected across different menstrual cycles among a subset of controls and/or cases (symptomatic patients).

There are no existing commercially available products for the diagnostic analysis of cells or tissues present in menstrual effluent for endometriosis or any other condition. To our knowledge this is no commercially available product for predicting endometriosis using peripheral blood or other biological specimens (other than the analysis of ectopic endometriosis lesions themselves). Currently, definitive diagnosis of endometriosis requires laparoscopic surgery and pathological analysis of the removed ectopic lesions.

Study Type

Observational

Enrollment (Estimated)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030-3816
        • Feinstein Institutes/Northwell health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The cohort will enroll a total of 185 menstruating individuals in total; 80 control subjects who self-report the general absence of symptoms of endometriosis and 105 symptomatic cases who report chronic symptoms* of endometriosis but who have not yet been diagnosed and are seeking physician evaluation for their symptoms.

Description

Inclusion Criteria:

For All

  • 18 to 40 year old menstruating women (continue to get cycles)
  • More than a light menstrual flow (light flow is soaking less than 1 thin pad or light tampon in 4 hours at peak flow)
  • Willingness to provide two menstrual samples across two separate menstrual cycles.
  • Willingness to provide a DNA sample (obtained via menstrual blood or cheek swab)

For Controls:

•General Absence of *symptoms suggestive of endometriosis which includes: 1-Chronic pelvic pain 2-Painful menses 3-Pain during intercourse 4-Pain going to the bathroom 5-Abdominal bloating (BUT MUST NOT Include): 6-Report of missed days of work, school, athletic,social and/or other activities due to related pain and discomfort

For Symptomatic:

  • Consistently Experiencing chronic symptoms of endometriosis*
  • Without definitive diagnosis
  • Seeking physician evaluation (considered by physician to be a candidate for laproscopic surgery
  • Willingness to provide one of the menstrual samples PRIOR to planned surgery
  • Surgical and pathological confirmation of endo (or NOT)

Exclusion Criteria:

For All:

  • under age 18 or over 40 years
  • Unable/unwilling to provide a menstrual sample
  • Light menstrual flow (light flow is soaking less than 1 thin pad or light tampon in 4 hours at peak flow)
  • Diagnosed with endometriosis

CONTROL:

  • More than 1 symptom of endometriosis*
  • Report of missed days of work, school, athletic, social and/or other activities due to related pain and discomfort

Symptomatic:

Unable to provide a menstrual sample prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Participant
Having No symptoms of Endo. Provide Menstrual samples.
Diagnostic test: Analysis of menstrual blood to predict endometriosis
Menstrual blood from controls and symptomatic cases will be analyzed using single cell RNA-sequencing to develop a panel of biomarkers that can be developed into a screening test or diagnostic test for endometriosis.
Symptomatic participant
Having symptoms of Endo and heading to diagnostic surgery as part of their standard of care (referred).
Diagnostic test: Analysis of menstrual blood to predict endometriosis
Menstrual blood from controls and symptomatic cases will be analyzed using single cell RNA-sequencing to develop a panel of biomarkers that can be developed into a screening test or diagnostic test for endometriosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROSE II: Pilot study to analyze menstrual blood to predict endometriosis
Time Frame: 2 years
The investigators will utilize single cell RNA sequencing analysis of stromal cells and uNK cells in menstrual effluent in order to define cellular and gene expression phenotypes that have been shown to be highly correlated with the presence of endometriosis
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROSE II: Pilot study to assess the progesterone sensitivity or resistance of cultured endometrial stromal cells
Time Frame: 2 years
The investigators will assess the response of endometrial stromal cells in menstrual blood to in vitro progesterone exposure using measurements of insulin growth factor binding protein 1 (IGFBP1) and prolactin (PRL).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Peter K Gregersen, MD, Northwell Health
  • Principal Investigator: Christine N Metz, PhD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The PIs on the study will determine with whom the de-identified samples will be shared. If we share any samples with other researchers, then we will remove all identifiers such as name or date of birth before sharing them.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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