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Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation.

Abstract：

OBJECTIVE:Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker study was designed by the NICHD Reproductive Medicine Network (RMN) to obtain well characterized and phenotyped bio specimens in a standardized fashion from women with and without endometriosis. DESIGN:Development of a diagnostic test. SETTING:Academic medical centers. PATIENTS:This study will enroll up to 500 participants, and follow them for up to 5 months. Included subjects are aged 18-44, scheduled to undergo gynecologic surgery (laparoscopy/laparotomy) for clinical reasons. INTERVENTIONS:Presence and stage of endometriosis (or its absence) is characterized by visual examination at the time of surgery. Subjects will undergo extensive clinical evaluation pre-operatively and at visits one and four months postoperatively. Endometrial biopsy, blood, urine and disease specific questionnaires will be collected at each visit. MAIN OUTCOME:Samples will be placed in a bio-repository to be used to validate and optimize the clinical use of genomic classifiers of the endometrium alone or in combination with serum cytokines as a non-surgical composite marker of endometriosis. CONCLUSION:This protocol can serve as a reference for objective collection of high quality bio specimens for discovery or validation of potential nonsurgical diagnosis of presence or severity of disease.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

Barnhart K,Giudice L,Young S,Thomas T,Diamond MP,Segars J,Youssef WA,Krawetz S,Santoro N,Eisenberg E,Zhang H,NICHD Cooperative Reproductive Medicine Network.

doi

10.1016/j.cct.2018.03.002

subject

Has Abstract

pub_date

2018-05-01 00:00:00

pages

1-6

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(17)30671-7

journal_volume

68

pub_type

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