Kurt Barnhart1, Linda Giudice2, Steve Young3, Tracey Thomas4, Michael P Diamond5, James Segars6, Wahid A Youssef7, Stephen Krawetz8, Nanette Santoro9, Esther Eisenberg10, Heping Zhang4. 1. Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu. 2. Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, United States. 3. Department of Obstetrics and Gynecology, Feinberg School of Medicine at Northwestern University, Chicago, IL, United States. 4. Department of Biostatistics, Yale University School of Public Health, New Haven, CT, United States. 5. Department of Obstetrics and Gynecology, Augusta University, Augusta, GA, United States. 6. Division of Reproductive Biology Research, Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, United States. 7. Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. 8. Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, United States. 9. Department of Obstetrics and Gynecology, University of Colorado, Denver, United States. 10. Reproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States.
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.
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.
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