Evidence map›Paper›PMID 29524590›Full record

ArticleContemporary clinical trials2018

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

Kurt Barnhart, Linda Giudice, Steve Young, Tracey Thomas, Michael P Diamond, James Segars, Wahid A Youssef, Stephen Krawetz, Nanette Santoro, Esther Eisenberg and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Endometriosis in the era of precision medicine and impact on sexual and reproductive health across the lifespan and in diverse populations.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

Kurt BarnhartDepartment of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu.
Linda GiudiceDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, United States.
Steve YoungDepartment of Obstetrics and Gynecology, Feinberg School of Medicine at Northwestern University, Chicago, IL, United States.
Tracey ThomasDepartment of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.
Michael P DiamondDepartment of Obstetrics and Gynecology, Augusta University, Augusta, GA, United States.
James SegarsDivision of Reproductive Biology Research, Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, United States.
Wahid A YoussefDepartment of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA, United States.
Stephen KrawetzDepartment of Obstetrics and Gynecology, Wayne State University, Detroit, MI, United States.
Nanette SantoroDepartment of Obstetrics and Gynecology, University of Colorado, Denver, United States.
Esther EisenbergReproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States.
Heping ZhangDepartment of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.
NICHD Cooperative Reproductive Medicine Network
Northwestern University · USUniversity of Pennsylvania · USYale University · USAugusta University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USWayne State University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Data Coordination Center for the RMNU10HD055925 · NICHD · YALE UNIVERSITY · PI ZHANG, HEPING · 2007 to 2019
$39.2M
Project 4: Human Endometrial Programming for Successful ImplantationP50HD055764 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GIUDICE, LINDA C · 2014 to 2022
$16.4M
Trophoblast Differentiation in In Vivo and In Vitro Fertilized EmbryosU54HD055764 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BLELLOCH, ROBERT · 2007 to 2013
$11.5M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD027049 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI COUTIFARIS, CHRISTOS · 1990 to 2017
$5.2M
GHSU/WSU Cooperative Reproductive Medicine NetworkU10HD039005 · NICHD · WAYNE STATE UNIVERSITY · PI DIAMOND, MICHAEL PETER · 2000 to 2017
$5.2M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD038992 · NICHD · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI LEGRO, RICHARD S. · 2000 to 2017
$5.0M
Cooperative Multicenter Reproductive Medicine Network UNC Clinical SiteU10HD077844 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI STEINER, ANNE ZWEIFEL · 2013 to 2017
$1.8M
Luteal Progesterone Supplementation in Clomiphene Citrate-IUI CyclesU10HD077680 · NICHD · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI HANSEN, KARL RICHARD · 2013 to 2017
$1.5M
NCATS NIH HHS UL1 TR001863NICHD NIH HHS P50 HD055764NICHD NIH HHS U10 HD027049NICHD NIH HHS U10 HD038992NICHD NIH HHS U10 HD039005NICHD NIH HHS U10 HD055925NICHD NIH HHS U10 HD077680NICHD NIH HHS U10 HD077844NICHD NIH HHS U54 HD055764
6 · The paper itself

Abstract

objectiveEndometriosis 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.

designDevelopment of a diagnostic test.

settingAcademic 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.

interventionsPresence 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.

conclusionThis 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.

Indexed as

BiomarkersEndometriosisAdultConservative TreatmentCytokinesEndometriumFemaleGenitaliaHumansPhenotypeReproducibility of ResultsSpecimen HandlingBiomarkersCytokinesBiomarkersCytokinesEndometriosisMicro RNAPhenotyping

Identifiers

PMID29524590
PMCPMC5899676
OpenAlexW2792330774

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.