Study Results
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Basic Information
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ENROLLING_BY_INVITATION
185 participants
OBSERVATIONAL
2022-05-27
2025-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Participant
Having No symptoms of Endo. Provide Menstrual samples.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Northwell Health
OTHER
Responsible Party
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Peter Gregersen
Professor and Director, Robert S. Boas Center for Genomics and Human Genetics
Principal Investigators
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Peter K Gregersen, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Christine N Metz, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Feinstein Institutes/Northwell health
Manhasset, New York, United States
Countries
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References
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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.
Ballard 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.
Brosens 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.
Bulun 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.
Chehna-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.
Drury 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.
Dunselman 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.
Johnston 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.
International 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.
Provided Documents
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Document Type: Study Protocol
Related Links
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Menstrual Effluent Provides a Novel Diagnostic Window on the Pathogenesis of Endometriosis
Single cell analysis of menstrual endometrial tissues defines phenotypes associated with endometriosis
Analysis of menstrual effluent: diagnostic potential for endometriosis
Other Identifiers
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22-0346
Identifier Type: -
Identifier Source: org_study_id
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