[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443232":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":51,"centralContacts":55,"locations":65,"responsibleParty":469,"collaborators":10,"id":471,"slug":472,"hasResults":473,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":473,"sex":479,"minAge":480,"maxAge":10,"enrollmentInfo":481,"targetDuration":10,"studyType":484,"phases":10,"briefSummary":485,"conditions":486,"keywords":10,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15,19,23,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 - AUB \u002F PMB",null,"Patients ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). Patients ages 18 - 44 years of age, presenting with abnormal uterine bleeding (AUB) and a risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.",[13,14],"Diagnostic Test: Vaginal Fluid Collection","Diagnostic Test: Blood Collection",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2 - Biopsy-proven EC or AEH or EIN","Patients ≥18 years of age with biopsy-proven endometrial cancer (EC), atypical endometrial hyperplasia (AEH), or endometrial intraepithelial neoplasia (EIN) presenting for surgical management of their endometrial pathology.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3 - Cervix pathology","Patients ≥18 years of age presenting for a clinically indicated colposcopy, cervical biopsy, or surgical excision, as follow-up for an abnormal Pap test or cervical mass identified on physical exam. Final clinical diagnoses within this cohort may include mild cervical intraepithelial neoplasia (CIN 1), moderate and\u002For severe CIN (CIN 2\u002F3), adenocarcinoma in situ (AIS), invasive cervical cancers (adenocarcinoma or squamous cell carcinoma), or possibly benign findings.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 4 - Benign Uterine Pathology","Patients with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All patients enrolled in this cohort will be undergoing clinically indicated gynecologic surgery (hysterectomy, myomectomy, polypectomy, or laparoscopic tissue excision) for the specific benign gynecologic condition. Verification of the final benign diagnosis will be based on pathology diagnosis of clinically-indicated tissue removed during surgery.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Cohort 5 - Healthy Control Women","Healthy patients with a uterus, ≥45 years of age presenting for GYN wellness exam to serve as a control group. These patients will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These patients will not have known or clinically suspected AUB, PMB, fibroids, endometriosis, benign endometrial polyps, or adenomyosis, nor will they have any active gynecologic or non-gynecologic acute medical conditions.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)","Patients ≥50 years of age and postmenopausal (12 months since LMP or available blood hormone levels confirming postmenopausal status) and an isolated adnexal mass or isolated bilateral adnexal masses being surgically removed. These patients may have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)","Patients ≥18 years of age with ovarian cancer (OC) (clinically probable based on distribution of pelvic\u002Fabdominal masses on imaging, elevated CA-125, ascites, and\u002For imaging-guided biopsy proven) presenting for neoadjuvant chemotherapy or primary surgical management (debulking or staging) of their OC. The umbrella of OC also includes fallopian tube cancer and primary peritoneal cancer. All histologies are eligible for enrollment.",[13,14],[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DIAGNOSTIC_TEST","Vaginal Fluid Collection","A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.",[9,16,20,24,28,32,36],[46],"Vaginal Fluid",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Blood Collection","A blood sample will be collected from each participant prior to undergoing any exams or procedures.",[9,16,20,24,28,32,36],[52],{"name":53,"affiliation":5,"role":54},"Jamie N. Bakkum-Gamez, M.D.","PRINCIPAL_INVESTIGATOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":10,"email":60},"Maureen A Lemens, BSN","CONTACT","507-293-1487","lemens.maureen@mayo.edu",{"name":62,"role":58,"phone":63,"phoneExt":10,"email":64},"Clinical Trials Referral Office","855-776-0015","mayocliniccancerstudies@mayo.edu",[66,86,102,112,128,147,156,176,193,212,221,242,259,272,293,310,321,342,361,378,398,419,440,460],{"facility":5,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-112.07404,33.44838,{"lat":77,"lon":76},[80,84],{"name":81,"role":58,"phone":82,"phoneExt":10,"email":83},"Favy Trujillo","480-574-1468","trujillo.faviola@mayo.edy",{"name":85,"role":54,"phone":10,"phoneExt":10,"email":10},"Kristina A. Butler, M.D.",{"facility":5,"status":67,"city":87,"state":88,"zip":89,"country":71,"countryCode":72,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Jacksonville","Florida","32224",{"type":74,"coordinates":91},[92,93],-81.65565,30.33218,{"lat":93,"lon":92},[96,100],{"name":97,"role":58,"phone":98,"phoneExt":10,"email":99},"Ashley N Shelton, CRC","504-953-1594","Shelton.Ashley@mayo.edu",{"name":101,"role":54,"phone":10,"phoneExt":10,"email":10},"Tri A. Dinh, M.D.",{"facility":103,"status":104,"city":105,"state":88,"zip":106,"country":71,"countryCode":72,"cosmosGeoPoint":107,"geoPoint":111,"contacts":10},"My GYN Care","ACTIVE_NOT_RECRUITING","Miami","33156",{"type":74,"coordinates":108},[109,110],-80.19366,25.77427,{"lat":110,"lon":109},{"facility":113,"status":67,"city":105,"state":88,"zip":114,"country":71,"countryCode":72,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Genoma Research, Inc.","33173",{"type":74,"coordinates":116},[109,110],{"lat":110,"lon":109},[119,123,125],{"name":120,"role":58,"phone":121,"phoneExt":10,"email":122},"Laura Lucia, BHSc, CRC","305-392-1264","lauralucia@genoma.comcastbiz.net",{"name":124,"role":54,"phone":10,"phoneExt":10,"email":10},"Guillermo Lievano, D.O.",{"name":126,"role":127,"phone":10,"phoneExt":10,"email":10},"Itsel Cardenas, PhD, APRN","SUB_INVESTIGATOR",{"facility":129,"status":67,"city":130,"state":88,"zip":131,"country":71,"countryCode":72,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Orlando Health","Orlando","32806",{"type":74,"coordinates":133},[134,135],-81.37924,28.53834,{"lat":135,"lon":134},[138,142,145],{"name":139,"role":58,"phone":140,"phoneExt":10,"email":141},"Donya Shahnavaz, CRC","321-841-7303","donya.shahnavaz@orlandohealth.com",{"name":143,"role":58,"phone":10,"phoneExt":10,"email":144},"Bianca Henry, CRC","bianca.henry@orlandohealth.com",{"name":146,"role":54,"phone":10,"phoneExt":10,"email":10},"Shelly M. Seward, M.D.",{"facility":148,"status":104,"city":149,"state":88,"zip":150,"country":71,"countryCode":72,"cosmosGeoPoint":151,"geoPoint":155,"contacts":10},"Signature Women's Healthcare, LLC","Pembroke Pines","33029",{"type":74,"coordinates":152},[153,154],-80.22394,26.00315,{"lat":154,"lon":153},{"facility":157,"status":67,"city":158,"state":88,"zip":159,"country":71,"countryCode":72,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Sarasota Memorial Health Care System","Sarasota","34239",{"type":74,"coordinates":161},[162,163],-82.53065,27.33643,{"lat":163,"lon":162},[166,169,172,174],{"name":167,"role":58,"phone":10,"phoneExt":10,"email":168},"Rachael Sanacore","Rachael-Sanacore@smh.com",{"name":170,"role":58,"phone":10,"phoneExt":10,"email":171},"Megan Swiger","Megan-Swiger@smh.com",{"name":173,"role":54,"phone":10,"phoneExt":10,"email":10},"Toni P Kilts, D.O.",{"name":175,"role":127,"phone":10,"phoneExt":10,"email":10},"Beverly J Long, M.D.",{"facility":177,"status":67,"city":178,"state":179,"zip":180,"country":71,"countryCode":72,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Piedmont Healthcare","Atlanta","Georgia","30318",{"type":74,"coordinates":182},[183,184],-84.38798,33.749,{"lat":184,"lon":183},[187,191],{"name":188,"role":58,"phone":189,"phoneExt":10,"email":190},"Dionne Jean, CRC","404-425-7927","dionne.jean@piedmont.org",{"name":192,"role":54,"phone":10,"phoneExt":10,"email":10},"Leda Portia A. Gattoc, M.D.",{"facility":194,"status":67,"city":195,"state":196,"zip":197,"country":71,"countryCode":72,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"University of Chicago","Chicago","Illinois","60637",{"type":74,"coordinates":199},[200,201],-87.65005,41.85003,{"lat":201,"lon":200},[204,207,210],{"name":205,"role":58,"phone":10,"phoneExt":10,"email":206},"Calla O'Connor, MPH","calla.oconnor@bsd.uchicago.edu",{"name":208,"role":58,"phone":10,"phoneExt":10,"email":209},"Veronika Sesari","vseseri@bsd.uchicago.edu",{"name":211,"role":54,"phone":10,"phoneExt":10,"email":10},"Kathryn Mills, M.D.",{"facility":213,"status":104,"city":214,"state":196,"zip":215,"country":71,"countryCode":72,"cosmosGeoPoint":216,"geoPoint":220,"contacts":10},"Providea Health Partners, LLC","Evergreen Park","60805",{"type":74,"coordinates":217},[218,219],-87.70172,41.72059,{"lat":219,"lon":218},{"facility":222,"status":67,"city":223,"state":224,"zip":225,"country":71,"countryCode":72,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Ochsner Clinic Foundation","New Orleans","Louisiana","70121",{"type":74,"coordinates":227},[228,229],-90.07507,29.95465,{"lat":229,"lon":228},[232,236,240],{"name":233,"role":58,"phone":234,"phoneExt":10,"email":235},"Ashley Samuel, CRC","504-703-2658","ashley.samuel@ochsner.org",{"name":237,"role":58,"phone":238,"phoneExt":10,"email":239},"Veronica Hixon Calliet, BSN","504-703-8602","veronica.hixoncalliet@ochsner.org",{"name":241,"role":54,"phone":10,"phoneExt":10,"email":10},"Diogo Torres, M.D.",{"facility":243,"status":67,"city":244,"state":245,"zip":246,"country":71,"countryCode":72,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Valley OB-GYN Clinic","Saginaw","Michigan","48602",{"type":74,"coordinates":248},[249,250],-83.95081,43.41947,{"lat":250,"lon":249},[253,257],{"name":254,"role":58,"phone":255,"phoneExt":10,"email":256},"Jacqueline Lang, CCRC","989-272-9065","jacqueline.lang@elligodirect.com",{"name":258,"role":54,"phone":10,"phoneExt":10,"email":10},"Olivia A. Phifer-Combs, M.D.",{"facility":5,"status":67,"city":260,"state":261,"zip":262,"country":71,"countryCode":72,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Rochester","Minnesota","55905",{"type":74,"coordinates":264},[265,266],-92.4699,44.02163,{"lat":266,"lon":265},[269,270],{"name":57,"role":58,"phone":59,"phoneExt":10,"email":60},{"name":271,"role":54,"phone":10,"phoneExt":10,"email":10},"Jamie N. Bakkum-Gamez, MD",{"facility":273,"status":67,"city":274,"state":275,"zip":276,"country":71,"countryCode":72,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"University of Mississippi Medical Center","Jackson","Mississippi","39213",{"type":74,"coordinates":278},[279,280],-90.18481,32.29876,{"lat":280,"lon":279},[283,287,291],{"name":284,"role":58,"phone":285,"phoneExt":10,"email":286},"Adriana Dodson, RN","601-984-1962","adodson2@umc.edu",{"name":288,"role":58,"phone":289,"phoneExt":10,"email":290},"Kenna H Nettles, PA-C","601-815-5963","knettles1@umc.edu",{"name":292,"role":54,"phone":10,"phoneExt":10,"email":10},"Rodney Rocconi, M.D.",{"facility":294,"status":67,"city":295,"state":296,"zip":297,"country":71,"countryCode":72,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"The Woman's Health Pavilion","Howard Beach","New York","11414",{"type":74,"coordinates":299},[300,301],-73.83625,40.65788,{"lat":301,"lon":300},[304,308],{"name":305,"role":58,"phone":306,"phoneExt":10,"email":307},"Monica Martinez, CRC","718-843-6300","mmartinez@ilovemygyn.com",{"name":309,"role":54,"phone":10,"phoneExt":10,"email":10},"Andre H. Saad, M.D.",{"facility":294,"status":67,"city":311,"state":296,"zip":312,"country":71,"countryCode":72,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Westbury","11590",{"type":74,"coordinates":314},[315,316],-73.58763,40.75566,{"lat":316,"lon":315},[319,320],{"name":305,"role":58,"phone":306,"phoneExt":10,"email":307},{"name":309,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":322,"status":67,"city":323,"state":324,"zip":325,"country":71,"countryCode":72,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Altru Health System","Grand Forks","North Dakota","58206",{"type":74,"coordinates":327},[328,329],-97.03285,47.92526,{"lat":329,"lon":328},[332,336,340],{"name":333,"role":58,"phone":334,"phoneExt":10,"email":335},"Alexis Tatum, CRC","701-780-1563","atatum@altru.org",{"name":337,"role":58,"phone":338,"phoneExt":10,"email":339},"Tina Schmitz, BSN","701-780-1845","tkschmitz@altru.org",{"name":341,"role":54,"phone":10,"phoneExt":10,"email":10},"Collette Lessard, M.D.",{"facility":343,"status":67,"city":344,"state":345,"zip":346,"country":71,"countryCode":72,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":74,"coordinates":348},[349,350],-81.69541,41.4995,{"lat":350,"lon":349},[353,356,359],{"name":354,"role":58,"phone":10,"phoneExt":10,"email":355},"Tori Carpenter, CRC","carpent3@ccf.org",{"name":357,"role":58,"phone":10,"phoneExt":10,"email":358},"Sarah Neale, CRC","neales@ccf.org",{"name":360,"role":54,"phone":10,"phoneExt":10,"email":10},"Michelle L. Kuznicki, M.D.",{"facility":362,"status":67,"city":363,"state":364,"zip":365,"country":71,"countryCode":72,"cosmosGeoPoint":366,"geoPoint":370,"contacts":371},"Total Women's Care of the Heights","Houston","Texas","77018",{"type":74,"coordinates":367},[368,369],-95.36327,29.76328,{"lat":369,"lon":368},[372,376],{"name":373,"role":58,"phone":374,"phoneExt":10,"email":375},"Tatiana Rivera","346-330-5302","ma@twcheights.com",{"name":377,"role":54,"phone":10,"phoneExt":10,"email":10},"Vonne Jones, M.D.",{"facility":379,"status":67,"city":380,"state":364,"zip":381,"country":71,"countryCode":72,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"Medical Colleagues of Texas, LLP","Katy","77450",{"type":74,"coordinates":383},[384,385],-95.8244,29.78579,{"lat":385,"lon":384},[388,392,396],{"name":389,"role":58,"phone":390,"phoneExt":10,"email":391},"Erika Keller, CRC","281-769-8674","erika.keller@elligodirect.com",{"name":393,"role":58,"phone":394,"phoneExt":10,"email":395},"Gabriella Coletta, CRC","512-351-4565","gabiella.coletta@elligodirect.com",{"name":397,"role":54,"phone":10,"phoneExt":10,"email":10},"Kelly A. McCullagh, M.D.",{"facility":399,"status":67,"city":400,"state":401,"zip":402,"country":71,"countryCode":72,"cosmosGeoPoint":403,"geoPoint":407,"contacts":408},"Virginia Commonwealth University\u002F Massey Cancer Center","Richmond","Virginia","23219",{"type":74,"coordinates":404},[405,406],-77.46026,37.55376,{"lat":406,"lon":405},[409,413,417],{"name":410,"role":58,"phone":411,"phoneExt":10,"email":412},"Morgan DeHart","804-827-1266","dehart2@vcu.edu",{"name":414,"role":58,"phone":415,"phoneExt":10,"email":416},"Faith McFadden, MSN","804-628-0616","mcfaddenfr@vcu.edu",{"name":418,"role":54,"phone":10,"phoneExt":10,"email":10},"Chelsea Salyer, M.D.",{"facility":420,"status":67,"city":421,"state":422,"zip":423,"country":71,"countryCode":72,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"Mayo Clinic Health System - Northwest Wisconsin","Eau Claire","Wisconsin","54703",{"type":74,"coordinates":425},[426,427],-91.49849,44.81135,{"lat":427,"lon":426},[430,434,438],{"name":431,"role":58,"phone":432,"phoneExt":10,"email":433},"Stephanie L Larson, ACRC","715-838-1976","larson.stephanie3@mayo.edu",{"name":435,"role":58,"phone":436,"phoneExt":10,"email":437},"Christina M Scinto, ACRC","715-464-8172","cinto.christina@mayo.edu",{"name":439,"role":54,"phone":10,"phoneExt":10,"email":10},"Blenda Yun, M.D.",{"facility":441,"status":67,"city":442,"state":422,"zip":443,"country":71,"countryCode":72,"cosmosGeoPoint":444,"geoPoint":448,"contacts":449},"Mayo Clinic Health System - Southwest Wisconsin","La Crosse","54601",{"type":74,"coordinates":445},[446,447],-91.23958,43.80136,{"lat":447,"lon":446},[450,454,458],{"name":451,"role":58,"phone":452,"phoneExt":10,"email":453},"Kate L Zboralski, ACRC","608-392-9521","zboralski.kathryn@mayo.edu",{"name":455,"role":58,"phone":456,"phoneExt":10,"email":457},"Taylor Cammer, ACRC","608-392-9280","cammer.taylor@mayo.edu",{"name":459,"role":54,"phone":10,"phoneExt":10,"email":10},"Rebecca A. Scarseth, D.O.",{"facility":461,"status":104,"city":462,"state":422,"zip":463,"country":71,"countryCode":72,"cosmosGeoPoint":464,"geoPoint":468,"contacts":10},"Medical College of Wisconsin","Milwaukee","53226",{"type":74,"coordinates":465},[466,467],-87.90647,43.0389,{"lat":467,"lon":466},{"type":470,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100443232","leveraging-methylated-dna-markers-mdms-in-the-detection-of-endometrial-cancer-ovarian-cancer-and-cervical-cancer-100443232",false,"NCT05051722","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study","ECHO","Inclusion Criteria for Cohort 1:\n\nPatients will be ≥45 years of age and meet one of the following criteria:\n\n* Abnormal uterine bleeding\n* Postmenopausal bleeding\n\nOR\n\nPatients ages 18 - 44 years of age and meet these criteria\n\n* Abnormal uterine bleeding\n* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)\n\nExclusion Criteria for Cohort 1:\n\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer or endometrial hyperplasia\n* Current biopsy-proven benign endometrial polyp\n* Endometrial biopsy\u002Fsampling within the preceding 1 month showing benign endometrium\n\nInclusion Criteria for Cohort 2:\n\nPatients will be ≥18 years of age and meet at least one of the following criteria:\n\n* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection\n* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection, etc)\n\nExclusion Criteria for Cohort 2:\n\n* Undergoing surgical procedure for recurrent or metastatic EC\n* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven cervical cancer\n* Presence of concomitant biopsy-proven cervical dysplasia\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Prior intervention or surgery with intent to completely remove the target pathology\n\nInclusion Criteria for Cohort 3:\n\nPatients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:\n\n* History of current abnormal cervical\u002Fendocervical Pap test for which the patient is presenting for colposcopy\n* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated\n* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)\n\nExclusion Criteria for Cohort 3:\n\n* History of pelvic or vaginal radiotherapy\n* Prior total hysterectomy (cervix removed) for any indication\n* Current known pregnancy diagnosis\n* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 4:\n\nPatients will be ≥45 years of age and should meet at least one of the following criteria:\n\n* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and\u002For clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.\n* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.\n\nExclusion Criteria for Cohort 4:\n\n* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 5:\n\nPatients with a uterus will be ≥45 years of age and should meet the following criteria:\n\n* Presenting for GYN wellness exam, ± Pap test\n* No change in medical conditions, new diagnoses, or new medications within the past 6 months\n\nExclusion Criteria for Cohort 5:\n\n* Pap test or cervical biopsy within the past 1 month\n* Endometrial biopsy or office hysteroscopy within the past 1 month\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Criteria met for inclusion in any of the other study cohorts\n\nInclusion Criteria for Cohort 6:\n\nPatients ≥50 years of age and:\n\n* Postmenopausal\n* At least 1 intact ovary\n* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)\n* Planned surgery for the adnexal mass\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 6:\n\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection\n* Surgical candidates for recurrent ovarian cancer\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n\nInclusion criteria for Cohort 7:\n\nWomen will be ≥18 years of age and meet the following criteria:\n\n* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any\u002Fall of the following: imaging showing adnexal and\u002For abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology\n* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy\n* At least one intact ovary\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 7:\n\n* Patients with recurrent OC\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n* Current known pregnancy diagnosis","FEMALE","18 Years",{"count":482,"type":483},3110,"ESTIMATED","OBSERVATIONAL","The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and\u002For plasma.\n\nThis proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.",[487,488,489,490,491,492],"Endometrial Cancer","Cervical Cancer","Atypical Endometrial Hyperplasia","Cervical Dysplasia","Adnexal Mass","Ovarian Cancer","2026-04-16",{"date":495,"type":496},"2026-04-17","ACTUAL",{"date":498,"type":496},"2021-08-03",{"date":500,"type":483},"2027-06-30",{"name":5,"class":6},24]