Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
3. januar 2020 opdateret af: Yale University
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery.
The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
114
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
- Augusta University
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Michigan
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Southfield, Michigan, Forenede Stater, 48034
- Wayne State University
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Pennsylvania State University
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 44 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Beskrivelse
Exclusion Criteria:
• Currently pregnant
- Current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer)
- Known to be HIV-positive
- Unable to give informed consent
- Unwillingness to have samples banked in Repository for future use
- Clinical evidence of active cervical infection
- Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron within the last 4 months)
Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).
o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).
- Use of depo estrogen or progestin in last 3 months
- Current use of aromatase inhibitor
Inclusion Criteria:
- Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Collection of up to 3 2cm samples of Endometrial Tissue
Tidsramme: 2 collection timepoints: baseline and up to 18 weeks following surgery.
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Up to 3 2cm samples will be collected per collection.
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2 collection timepoints: baseline and up to 18 weeks following surgery.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Collection of Serum 1 will be 2 10ml serum tubes of serum
Tidsramme: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Collection of Serum 2 will be 2 7 ml serum tubes of serum
Tidsramme: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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2 7ml serum tubes drawn at each collection, up to 10 1.0ml aliquots of serum plus 1 15ml conical tube with the 2 blood clots per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Collection of Plasma in 1 4ml EDTA tube
Tidsramme: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Collection of Whole Blood in 2 4ml EDTA tubes
Tidsramme: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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2 4ml EDTA tubes will be drawn at each collection, up to 2 4.5ml aliquots as well as 1 FTA blood spot collection card per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Collection of Urine will be one complete sample as produced by the subject
Tidsramme: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Nanette Santoro, MD, University of Colorado, Denver
- Studieleder: Esther Eisenberg, MD MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Ledende efterforsker: Kurt Barnhart, MD MSCE, University of Pennsylvania
- Ledende efterforsker: Michael Diamond, MD, Augusta University
- Ledende efterforsker: Richard Legro, MD, Milton S. Hershey Medical Center
- Ledende efterforsker: Marcelle Cedars, MD, University of California, San Francisco
- Ledende efterforsker: Anne Steiner, MD MPH, University of North Carolina
- Ledende efterforsker: Karl Hansen, MD PhD, University of Oklahoma
- Ledende efterforsker: Christos Coutifaris, MD PhD, University of Pennsylvania
- Ledende efterforsker: Heping Zhang, PhD, Yale University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. juli 2016
Primær færdiggørelse (Faktiske)
1. august 2019
Studieafslutning (Faktiske)
1. december 2019
Datoer for studieregistrering
Først indsendt
13. november 2015
Først indsendt, der opfyldte QC-kriterier
18. maj 2017
Først opslået (Faktiske)
22. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENDOmarker
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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