Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:38 PM
Study NCT ID:
NCT07400835
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-24
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of DNA Methylation Markers for Endometrial Cancer Risk-stratification Using Patient-collected Urine and Vaginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patient-collected urine and vaginal samples, and clinician-collected cervical samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Curve (AUC)', 'timeFrame': 'At the time of enrollment and to the time of diagnosis', 'description': 'The performance of each methylation marker panels in urine, vaginal and cervical samples and the TVUS will be evaluated by area Under the Curve with 95% CIs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DNA methylation', 'Postmenopausal bleeding', 'Endometrial Cancer', 'Patient-collected urine samples', 'cervical samples', 'Patient-collected vaginal samples'], 'conditions': ['Postmenopausal Bleeding']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '35397864', 'type': 'BACKGROUND', 'citation': 'Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.'}, {'pmid': '20491528', 'type': 'BACKGROUND', 'citation': 'Engholm G, Ferlay J, Christensen N, Bray F, Gjerstorff ML, Klint A, Kotlum JE, Olafsdottir E, Pukkala E, Storm HH. NORDCAN--a Nordic tool for cancer information, planning, quality control and research. Acta Oncol. 2010 Jun;49(5):725-36. doi: 10.3109/02841861003782017.'}, {'pmid': '32683690', 'type': 'BACKGROUND', 'citation': 'Gustafson LW, Booth BB, Kahlert J, Ortoft G, Mejlgaard E, Clarke MA, Wentzensen N, Rositch AF, Hammer A. Trends in hysterectomy-corrected uterine cancer mortality rates during 2002 to 2015: mortality of nonendometrioid cancer on the rise? Int J Cancer. 2021 Feb 1;148(3):584-592. doi: 10.1002/ijc.33219. Epub 2020 Aug 17.'}, {'pmid': '32008795', 'type': 'BACKGROUND', 'citation': 'Long B, Clarke MA, Morillo ADM, Wentzensen N, Bakkum-Gamez JN. Ultrasound detection of endometrial cancer in women with postmenopausal bleeding: Systematic review and meta-analysis. Gynecol Oncol. 2020 Jun;157(3):624-633. doi: 10.1016/j.ygyno.2020.01.032. Epub 2020 Jan 31.'}, {'pmid': '14756741', 'type': 'BACKGROUND', 'citation': 'Astrup K, Olivarius Nde F. Frequency of spontaneously occurring postmenopausal bleeding in the general population. Acta Obstet Gynecol Scand. 2004 Feb;83(2):203-7. doi: 10.1111/j.0001-6349.2004.00400.x.'}, {'pmid': '36001862', 'type': 'BACKGROUND', 'citation': 'Herzog C, Marin F, Jones A, Evans I, Reisel D, Redl E, Schreiberhuber L, Paytubi S, Pelegrina B, Carmona A, Peremiquel-Trillas P, Frias-Gomez J, Pineda M, Brunet J, Ponce J, Matias-Guiu X, de Sanjose S, Alemany L, Olaitan A, Wong M, Jurkovic D, Crosbie EJ, Rosenthal AN, Bjorge L, Zikan M, Dostalek L, Cibula D, Sundstrom K, Dillner J, Costas L, Widschwendter M. A Simple Cervicovaginal Epigenetic Test for Screening and Rapid Triage of Women With Suspected Endometrial Cancer: Validation in Several Cohort and Case/Control Sets. J Clin Oncol. 2022 Nov 20;40(33):3828-3838. doi: 10.1200/JCO.22.00266. Epub 2022 Aug 24.'}, {'pmid': '26354523', 'type': 'BACKGROUND', 'citation': 'Morice P, Leary A, Creutzberg C, Abu-Rustum N, Darai E. Endometrial cancer. Lancet. 2016 Mar 12;387(10023):1094-1108. doi: 10.1016/S0140-6736(15)00130-0. Epub 2015 Sep 6.'}, {'pmid': '33143739', 'type': 'BACKGROUND', 'citation': 'van den Helder R, Wever BMM, van Trommel NE, van Splunter AP, Mom CH, Kasius JC, Bleeker MCG, Steenbergen RDM. Non-invasive detection of endometrial cancer by DNA methylation analysis in urine. Clin Epigenetics. 2020 Nov 3;12(1):165. doi: 10.1186/s13148-020-00958-7.'}, {'pmid': '20920744', 'type': 'BACKGROUND', 'citation': 'Kulis M, Esteller M. DNA methylation and cancer. Adv Genet. 2010;70:27-56. doi: 10.1016/B978-0-12-380866-0.60002-2.'}, {'pmid': '33572525', 'type': 'BACKGROUND', 'citation': 'Hentschel AE, van den Helder R, van Trommel NE, van Splunter AP, van Boerdonk RAA, van Gent MDJM, Nieuwenhuijzen JA, Steenbergen RDM. The Origin of Tumor DNA in Urine of Urogenital Cancer Patients: Local Shedding and Transrenal Excretion. Cancers (Basel). 2021 Jan 31;13(3):535. doi: 10.3390/cancers13030535.'}, {'pmid': '32938224', 'type': 'BACKGROUND', 'citation': 'den Helder RV, Wever BM, van Trommel JA, Ket JC, Bleeker MC, Steenbergen RD, van Trommel NE. DNA methylation markers for endometrial cancer detection in minimally invasive samples: a systematic review. Epigenomics. 2020 Sep;12(18):1661-1672. doi: 10.2217/epi-2020-0164. Epub 2020 Sep 17.'}, {'pmid': '15159323', 'type': 'BACKGROUND', 'citation': 'Fiegl H, Gattringer C, Widschwendter A, Schneitter A, Ramoni A, Sarlay D, Gaugg I, Goebel G, Muller HM, Mueller-Holzner E, Marth C, Widschwendter M. Methylated DNA collected by tampons--a new tool to detect endometrial cancer. Cancer Epidemiol Biomarkers Prev. 2004 May;13(5):882-8.'}, {'pmid': '23727823', 'type': 'BACKGROUND', 'citation': 'Doufekas K, Hadwin R, Kandimalla R, Jones A, Mould T, Crowe S, Olaitan A, Macdonald N, Fiegl H, Wik E, Salvesen HB, Widschwendter M. GALR1 methylation in vaginal swabs is highly accurate in identifying women with endometrial cancer. Int J Gynecol Cancer. 2013 Jul;23(6):1050-5. doi: 10.1097/IGC.0b013e3182959103.'}, {'pmid': '23016466', 'type': 'BACKGROUND', 'citation': 'Kim GE, Kweon SS, Lee JS, Lee JH, Nam JH, Choi C. Quantitative assessment of DNA methylation for the detection of cervical and endometrial adenocarcinomas in liquid-based cytology specimens. Anal Quant Cytopathol Histpathol. 2012 Aug;34(4):195-203.'}, {'pmid': '25281766', 'type': 'BACKGROUND', 'citation': 'De Strooper LM, van Zummeren M, Steenbergen RD, Bleeker MC, Hesselink AT, Wisman GB, Snijders PJ, Heideman DA, Meijer CJ. CADM1, MAL and miR124-2 methylation analysis in cervical scrapes to detect cervical and endometrial cancer. J Clin Pathol. 2014 Dec;67(12):1067-71. doi: 10.1136/jclinpath-2014-202616. Epub 2014 Oct 3.'}, {'pmid': '37141817', 'type': 'BACKGROUND', 'citation': "Bakkum-Gamez JN, Sherman ME, Slettedahl SW, Mahoney DW, Lemens MA, Laughlin-Tommaso SK, Hopkins MR, VanOosten A, Shridhar V, Staub JK, Cao X, Foote PH, Clarke MA, Burger KN, Berger CK, O'Connell MC, Doering KA, Podratz KC, DeStephano CC, Schoolmeester JK, Kerr SE, Wentzensen N, Taylor WR, Kisiel JB. Detection of endometrial cancer using tampon-based collection and methylated DNA markers. Gynecol Oncol. 2023 Jul;174:11-20. doi: 10.1016/j.ygyno.2023.04.014. Epub 2023 May 2."}, {'pmid': '36912267', 'type': 'BACKGROUND', 'citation': 'Wever BMM, van den Helder R, van Splunter AP, van Gent MDJM, Kasius JC, Trum JW, Verhoeve HR, van Baal WM, Hulbert A, Verhoef L, Heideman DAM, Lissenberg-Witte BI, van Trommel NE, Steenbergen RDM, Bleeker MCG. DNA methylation testing for endometrial cancer detection in urine, cervicovaginal self-samples and cervical scrapes. Int J Cancer. 2023 Jul 15;153(2):341-351. doi: 10.1002/ijc.34504. Epub 2023 Mar 23.'}, {'pmid': '30816167', 'type': 'BACKGROUND', 'citation': 'Snoek BC, Splunter APV, Bleeker MCG, Ruiten MCV, Heideman DAM, Rurup WF, Verlaat W, Schotman H, Gent MV, Trommel NEV, Steenbergen RDM. Cervical cancer detection by DNA methylation analysis in urine. Sci Rep. 2019 Feb 28;9(1):3088. doi: 10.1038/s41598-019-39275-2.'}, {'pmid': '27671338', 'type': 'BACKGROUND', 'citation': 'Guerrero-Preston R, Valle BL, Jedlicka A, Turaga N, Folawiyo O, Pirini F, Lawson F, Vergura A, Noordhuis M, Dziedzic A, Perez G, Renehan M, Guerrero-Diaz C, De Jesus Rodriguez E, Diaz-Montes T, Rodriguez Orengo J, Mendez K, Romaguera J, Trock BJ, Florea L, Sidransky D. Molecular Triage of Premalignant Lesions in Liquid-Based Cervical Cytology and Circulating Cell-Free DNA from Urine, Using a Panel of Methylated Human Papilloma Virus and Host Genes. Cancer Prev Res (Phila). 2016 Dec;9(12):915-924. doi: 10.1158/1940-6207.CAPR-16-0138. Epub 2016 Sep 26.'}, {'pmid': '33846517', 'type': 'BACKGROUND', 'citation': 'Van Keer S, van Splunter AP, Pattyn J, De Smet A, Herzog SA, Van Ostade X, Tjalma WAA, Ieven M, Van Damme P, Steenbergen RDM, Vorsters A. Triage of human papillomavirus infected women by methylation analysis in first-void urine. Sci Rep. 2021 Apr 12;11(1):7862. doi: 10.1038/s41598-021-87329-1.'}, {'pmid': '37944542', 'type': 'BACKGROUND', 'citation': 'Evans I, Reisel D, Jones A, Bajrami A, Nijjar S, Solangon SA, Arora R, Redl E, Schreiberhuber L, Ishaq-Parveen I, Rotharmel J, Herzog C, Jurkovic D, Widschwendter M. Performance of the WID-qEC test versus sonography to detect uterine cancers in women with abnormal uterine bleeding (EPI-SURE): a prospective, consecutive observational cohort study in the UK. Lancet Oncol. 2023 Dec;24(12):1375-1386. doi: 10.1016/S1470-2045(23)00466-7. Epub 2023 Nov 6.'}, {'pmid': '20865103', 'type': 'BACKGROUND', 'citation': 'Erichsen R, Lash TL, Hamilton-Dutoit SJ, Bjerregaard B, Vyberg M, Pedersen L. Existing data sources for clinical epidemiology: the Danish National Pathology Registry and Data Bank. Clin Epidemiol. 2010 Aug 9;2:51-6. doi: 10.2147/clep.s9908.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the clinical utility of DNA-methylation testing in urine and vaginal samples collected by patients and cervical samples collected by clinicians, to determine the risk of endometrial cancer in symptomatic women with postmenopausal bleeding. The study aims to answer the following research questions:\n\n* What is the diagnostic accuracy of DNA methylation testing in urine, vaginal and cervical samples compared to traditional TVUS for endometrial cancer detection?\n* What is the 2-year risk of EC among women testing negative on TVUS and/or DNA methylation tests or those testing positive on methylation only?\n\nResearchers will compare DNA methylation testing in patient-collected urine and vaginal samples as well as in clinician-collected cervical samples, with the traditional diagnostic pathway for women with PMB, which includes TVUS evaluation, and when indicated by abnormal TVUS findings, endometrial biopsy according to clinical guidelines.\n\nParticipants will\n\n* take a urine and vaginal sample\n* have a cervical sample collected by a clinician\n* undergo TVUS evaluation according to clinical guidelines\n* If TVUS shows thickened endometrium (≥ 5 mm) and/or irregularity, an endometrial biopsy will be collected according to clinical guidelines\n* fill out a questionnaire regarding acceptability and preferences of sampling methods and complete a lifestyle questionnaire.', 'detailedDescription': "BACKGROUND:\n\nEndometrial cancer (EC) incidence is rising and is the fourth most common cancer type in women worldwide with about 417,000 new cases and 90,000 deaths annually. Moreover, EC is the most common gynaecological cancer in developed countries including Denmark with about 800 new cases and 90 deaths yearly. Early diagnosis is essential since the prognosis for women with an advanced-stage EC is poor. No screening exists for EC and the most commonly observed clinical symptom is post-menopausal bleeding (PMB), which is a common condition affecting about 11% of postmenopausal women. Because 90% of EC cases, are preceded by PMB, referral for specialized gynaecological care through cancer patient pathways is indicated for all Danish women with PMB, causing anxiety among women and high healthcare costs. However, only 5-10% of women presenting with PMB have EC. Worldwide, transvaginal ultrasound (TVUS) evaluation of the endometrium (cut-off: thickness ≥5mm and/or irregular lining of the uterine cavity) is used to identify women with PMB who have the highest cancer risk and therefore require an endometrial biopsy with or without hysteroscopy. While TVUS evaluation is highly sensitive (94.8%) it suffers from low specificity (51%) causing high numbers of unnecessary invasive procedures in healthy women. Moreover, the diagnostic program depends on skilled specialists for ultrasound evaluation, endometrial sampling as well as histopathological examination. This reinforces the clinical urgent and unmet need for a simpler, non-invasive, user-provided and more specific test to aid EC diagnosis.\n\nThis study aims to determine whether DNA methylation testing in patient-collected urine and vaginal samples is a clinically safe non-invasive alternative to determine EC risk. Testing for elevated DNA hypermethylation levels of cancer-specific genes has been demonstrated to provide a promising biomarker for detection of early-stage cancers, including cervical and endometrial cancer. DNA hypermethylation has been linked to silencing of tumour suppressor genes, thereby contributing to cancer development. Biologically, the ability to use vaginal and urine material for EC detection by DNA methylation testing is explained by local shedding of EC-derived DNA and cell fragments into the vaginal debris and urine as well as transrenal excretion of tumour-shed circulating DNA into the urine.\n\nMainly small proof-of-concept and case-control studies have shown feasibility for detecting EC using DNA methylation testing in plasma, self-collected vaginal samples, and clinician-collected cervical scrapes. However, the first paper reporting on the diagnostic value of DNA methylation analysis in vaginal samples and urine as a liquid biopsy for EC was just published by co-supervisor Prof. Steenbergen last year. Here, case-control data revealed excellent diagnostic performance of EC-specific DNA methylation markers in patient-collected urine and vaginal samples with sensitivities of 89-90% and specificities of 90-92% for EC detection using marker panels including: CDH13, GHSR, SST, CDO1, and ZIC1.\n\nOnly one prospective cohort study has compared the diagnostic performance of DNA methylation testing in clinician-collected cervicovaginal samples with the conventional TVUS evaluation in terms of detecting the presence or absence of EC in women aged 45+ with abnormal uterine bleeding. The results demonstrated the WID-qEC DNA methylation test (markers: ZSCAN12 and GYPC) to have equal sensitivity (90.9%) and superior specificity (92.1 vs 79.1%) as compared with TVUS evaluation.\n\nHowever, this will be the first study to compare DNA methylation testing in patient-collected urine and vaginal samples with TVUS evaluation.\n\nSTUDY DESIGN: Comparative diagnostic accuracy study, comparing diagnostic test methods at the time of diagnosis as well as the long-term safety after two years.\n\nMATERIALS AND METHODS:\n\nThe vaginal, urine and cervical samples will be stored in a biobank at the Dept. of Pathology, Randers Regional Hospital (RHR) until shipment for DNA methylation testing analysis using quantitative methylation-specific PCR (qMSP) in Prof. Steenbergen's laboratory at Amsterdam University Medical Centre, The Netherlands. All samples will be tested for methylation markers, three for vaginal samples (CDO1, GHSR, ZIC1), three for urine (GHSR, CDH13, SST) and three for cervical samples (CDH13 + CDO1 + ZIC1). Results on TVUS evaluation and endometrial biopsies will be retrieved from the nationwide Danish Pathology Databank and the electronic patient journal linked to the patient through the Civil Registration System in Denmark, where all residents have a unique 10-digit code (CPR number), to which all health data is linked.\n\nAIMs:\n\n1\\) To determine the diagnostic accuracy of DNA methylation testing in patient-collected full-void urine and vaginal samples, as well as clinician-collected cervical samples to detect EC among women with postmenopausal bleeding, and 2) to compare the diagnostic test accuracy of DNA methylation with the current diagnostic evaluation with TVUS.\n\nHYPOTHESES:\n\n1. DNA methylation testing in urine samples can detect EC with comparable sensitivity and superior specificity compared with TVUS and with higher accuracy than DNA methylation testing in vaginal and cervical samples.\n2. DNA methylation analysis in urine samples will have a long-term negative EC risk after 2 years equivalent to TVUS, but better than vaginal and cervical samples.\n\nRESEARCH PLAN AND FEASIBILITY The study will be conducted in collaboration between University Clinic for Cancer Screening, Department of Public Health Programmes, Department of Pathology, RHR and with gynaecological departments in Central Denmark (Randers and Aarhus) and Southern Denmark Region (Odense) working as inclusion sites. State-of-the-art laboratory facilities are in place at Prof. Steenbergen's laboratory at Amsterdam UMC, supporting the feasibility of the study.\n\nPERSPECTIVES AND COMMUNICATION If successful, the research will have international impact and result in a novel diagnostic tool that will differentiate between women with PMB who do or do not need specialist referral through cancer patients' pathways to have invasive endometrial biopsies. This will facilitate timely diagnosis, lower the anxiety among patients, and reduce the pressure on the healthcare system. Results will be published in international peer-reviewed journals and presented at conferences and will be concluded with a PhD dissertation. The results will be distributed to relevant clinical fora and implemented in national as well as international guidelines."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with postmenopausal bleeding undergoing diagnostic evaluation for endometrial cancer will be recruited from Department of Obstetrics and Gynaecology, Aarhus University Hospital, Randers Regional Hospital, Central Denmark Region, and Odense University Hospital, Southern Denmark Region, Denmark.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal bleeding (defined as vaginal bleeding after absence of periods for ≥ 12 months) undergoing diagnostic evaluation for EC at gynaecological departments\n* Treated in Central Denmark Region or Southern Denmark Region, Denmark\n* Able to provide written consent for participation\n* Able to read and understand Danish\n\nExclusion Criteria:\n\n* Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding\n* Withdrawal of consent\n* Hysterectomized'}, 'identificationModule': {'nctId': 'NCT07400835', 'briefTitle': 'Evaluation of DNA Methylation Markers for Endometrial Cancer Risk-stratification Using Patient-collected Urine and Vaginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The ENDOMETRIAL Study: EvaluatioN of DNA methylatiOn Markers for EndomeTrial Cancer Risk-stratification Using Patient-collected urIne and vAginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal bLeeding', 'orgStudyIdInfo': {'id': 'endometrial-PMB-stúdy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with postmenopausal bleeding', 'description': 'Women referred for diagnostic evaluation to gynaecological departments for endometrial cancer due to postmenopausal bleeding', 'interventionNames': ['Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples']}], 'interventions': [{'name': 'DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples, GHSR, CDH13 and SST for patient-collected urine samples and CDH13 + CDO1 + ZIC1 for clinician-collected cervical samples.', 'armGroupLabels': ['Women with postmenopausal bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynaecology, Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynaecology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynaecology, Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'overallOfficials': [{'name': 'Mette Tranberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Denmark Region', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Central Denmark Region', 'class': 'UNKNOWN'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Amsterdam UMC', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}