EndometriosisROSE2NCT05601596
Research OutSmarts Endometriosis II Study
An observational study of Endometriosis, run by Northwell Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Analysis of menstrual blood to predict endometriosis
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The cohort will enroll a total of 250 menstruating individuals in total; 108 control subjects who self-report the general absence of symptoms of endometriosis and 142 symptomatic cases who report chronic symptoms* of endometriosis but who have not yet been diagnosed and are seeking physician evaluation for their symptoms.
Who may be able to join
- 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:
Show all 13Show fewer
- •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 (i.e. pathology report following diagnostic surgery)
- Seeking physician evaluation (considered by physician to be a candidate for laproscopic surgery
- Willingness to provide at least one of the menstrual samples PRIOR to planned surgery
- Surgical and pathological confirmation of endo (or NOT)
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Feinstein Institutes/Northwell health
Manhasset, New York, 11030-3816
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Analysis of menstrual blood to predict endometriosis
- Keywords
- Diagnosis
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of menstrual blood to predict endometriosisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Participant | Having No symptoms of Endo. Provide Menstrual samples. Receives: Diagnostic Test: Analysis of menstrual blood to predict endometriosis | |
| Symptomatic participant | Having symptoms of Endo and heading to diagnostic surgery as part of their standard of care (referred). Receives: Diagnostic Test: Analysis of menstrual blood to predict endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROSE II: Pilot study to analyze menstrual blood to predict endometriosis
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
Measured: 2 years
Secondary outcomes (1)
ROSE II: Pilot study to assess the progesterone sensitivity or resistance of cultured endometrial stromal cells
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start27 May 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gregersen, Northwell Health
- Investigators
- Peter K Gregersen, MD, Principal investigator, Northwell HealthChristine N Metz, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601596
- Sponsor's protocol ID
- 22-0346
- Acronym
- ROSE2
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Aghajanova L, Giudice LC. Molecular evidence for differences in endometrium in severe versus mild endometriosis. Reprod Sci. 2011 Mar;18(3):229-51. doi: 10.1177/1933719110386241. Epub 2010 Nov 9.
PubMed 21063030Ballard K, Lowton K, Wright J. What's the delay? A qualitative study of women's experiences of reaching a diagnosis of endometriosis. Fertil Steril. 2006 Nov;86(5):1296-301. doi: 10.1016/j.fertnstert.2006.04.054.
PubMed 17070183Brosens I, Brosens JJ, Benagiano G. The eutopic endometrium in endometriosis: are the changes of clinical significance? Reprod Biomed Online. 2012 May;24(5):496-502. doi: 10.1016/j.rbmo.2012.01.022. Epub 2012 Jan 31.
PubMed 22417665Bulun SE, Cheng YH, Yin P, Imir G, Utsunomiya H, Attar E, Innes J, Julie Kim J. Progesterone resistance in endometriosis: link to failure to metabolize estradiol. Mol Cell Endocrinol. 2006 Mar 27;248(1-2):94-103. doi: 10.1016/j.mce.2005.11.041. Epub 2006 Jan 10.
PubMed 16406281Chehna-Patel N, Sachdeva G, Gajbhiye R, Warty N, Khole V. "Spot"-ting differences between the ectopic and eutopic endometrium of endometriosis patients. Fertil Steril. 2010 Nov;94(6):1964-71, 1971.e1. doi: 10.1016/j.fertnstert.2010.01.048. Epub 2010 Mar 16.
PubMed 20236630Drury JA, Parkin KL, Coyne L, Giuliani E, Fazleabas AT, Hapangama DK. The dynamic changes in the number of uterine natural killer cells are specific to the eutopic but not to the ectopic endometrium in women and in a baboon model of endometriosis. Reprod Biol Endocrinol. 2018 Jul 18;16(1):67. doi: 10.1186/s12958-018-0385-3.
PubMed 30021652Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.
PubMed 24435778Johnston JL, Reid H, Hunter D. Diagnosing endometriosis in primary care: clinical update. Br J Gen Pract. 2015 Feb;65(631):101-2. doi: 10.3399/bjgp15X683665. No abstract available.
PubMed 25624305International working group of AAGL, ESGE, ESHRE and WES; Tomassetti C, Johnson NP, Petrozza J, Abrao MS, Einarsson JI, Horne AW, Lee TTM, Missmer S, Vermeulen N, Zondervan KT, Grimbizis G, De Wilde RL. An International Terminology for Endometriosis, 2021. J Minim Invasive Gynecol. 2021 Nov;28(11):1849-1859. doi: 10.1016/j.jmig.2021.08.032. Epub 2021 Oct 21.
PubMed 34690084
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSE II: Pilot Study to Analyze Menstrual Blood to Predict Endometriosis
- ClinicalTrials.gov ID
- NCT05601596
- Acronym / sponsor ID
- ROSE2 / 22-0346
- Conditions
- Endometriosis
- Keywords
- Diagnosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Participant | – | Diagnostic Test: Analysis of menstrual blood to predict endometriosisHaving No symptoms of Endo. Provide Menstrual samples. |
| Symptomatic participant | – | Diagnostic Test: Analysis of menstrual blood to predict endometriosisHaving symptoms of Endo and heading to diagnostic surgery as part of their standard of care (referred). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The cohort will enroll a total of 250 menstruating individuals in total; 108 control subjects who self-report the general absence of symptoms of endometriosis and 142 symptomatic cases who report chronic symptoms* of endometriosis but who have not yet been diagnosed and are seeking physician evaluation for their symptoms.
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
- More than 1 symptom of endometriosis*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of menstrual blood to predict endometriosisMenstrual 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. | Diagnostic test | Control Participant, Symptomatic participant |
Primary outcome
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
1 secondary outcome
ROSE II: Pilot study to assess the progesterone sensitivity or resistance of cultured endometrial stromal cells
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 21063030Aghajanova L, Giudice LC. Molecular evidence for differences in endometrium in severe versus mild endometriosis. Reprod Sci. 2011 Mar;18(3):229-51. doi: 10.1177/1933719110386241. Epub 2010 Nov 9.
- Background: PubMed 17070183Ballard K, Lowton K, Wright J. What's the delay? A qualitative study of women's experiences of reaching a diagnosis of endometriosis. Fertil Steril. 2006 Nov;86(5):1296-301. doi: 10.1016/j.fertnstert.2006.04.054.
- Background: PubMed 22417665Brosens I, Brosens JJ, Benagiano G. The eutopic endometrium in endometriosis: are the changes of clinical significance? Reprod Biomed Online. 2012 May;24(5):496-502. doi: 10.1016/j.rbmo.2012.01.022. Epub 2012 Jan 31.
- Background: PubMed 16406281Bulun SE, Cheng YH, Yin P, Imir G, Utsunomiya H, Attar E, Innes J, Julie Kim J. Progesterone resistance in endometriosis: link to failure to metabolize estradiol. Mol Cell Endocrinol. 2006 Mar 27;248(1-2):94-103. doi: 10.1016/j.mce.2005.11.041. Epub 2006 Jan 10.
- Background: PubMed 20236630Chehna-Patel N, Sachdeva G, Gajbhiye R, Warty N, Khole V. "Spot"-ting differences between the ectopic and eutopic endometrium of endometriosis patients. Fertil Steril. 2010 Nov;94(6):1964-71, 1971.e1. doi: 10.1016/j.fertnstert.2010.01.048. Epub 2010 Mar 16.
- Background: PubMed 30021652Drury JA, Parkin KL, Coyne L, Giuliani E, Fazleabas AT, Hapangama DK. The dynamic changes in the number of uterine natural killer cells are specific to the eutopic but not to the ectopic endometrium in women and in a baboon model of endometriosis. Reprod Biol Endocrinol. 2018 Jul 18;16(1):67. doi: 10.1186/s12958-018-0385-3.
- Background: PubMed 24435778Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.
- Background: PubMed 25624305Johnston JL, Reid H, Hunter D. Diagnosing endometriosis in primary care: clinical update. Br J Gen Pract. 2015 Feb;65(631):101-2. doi: 10.3399/bjgp15X683665. No abstract available.
- Background: PubMed 34690084International working group of AAGL, ESGE, ESHRE and WES; Tomassetti C, Johnson NP, Petrozza J, Abrao MS, Einarsson JI, Horne AW, Lee TTM, Missmer S, Vermeulen N, Zondervan KT, Grimbizis G, De Wilde RL. An International Terminology for Endometriosis, 2021. J Minim Invasive Gynecol. 2021 Nov;28(11):1849-1859. doi: 10.1016/j.jmig.2021.08.032. Epub 2021 Oct 21.
- Menstrual Effluent Provides a Novel Diagnostic Window on the Pathogenesis of EndometriosisLink provided by the sponsor.
- Analysis of menstrual effluent: diagnostic potential for endometriosisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter K Gregersen, MD principal investigator
Northwell Health
Christine N Metz, PhD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROSE II: Pilot study to analyze menstrual blood to predict endometriosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601596, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.