protocolSection identificationModule nctId: NCT06268626, orgStudyIdInfo id: H22-02426, secondaryIdInfos id: F22-01302, type: OTHER_GRANT, domain: Canadian Institutes of Health Research (CIHR), secondaryIdInfos id: F21-03695, type: OTHER_GRANT, domain: Canadian Institutes of Health Research (CIHR), briefTitle: Detection of Endometrial Cancer Through Risk Modelling, acronym: DETECTR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later., conditionsModule conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Association Between Risk Factor Data and Endometrial Cancer and It's Precursors., primaryOutcomes measure: Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone., primaryOutcomes measure: Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia., eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VGH Research Pavilion, city: Vancouver, state: British Columbia, zip: V5Z 1M9, country: Canada, contacts name: Aline Talhouk, PhD, role: CONTACT, phone: +1 (604) 875-4111, phoneExt: 21365, email: a.talhouk@ubc.ca, contacts name: Elise Abi Khalil, PhD, role: CONTACT, phone: +1 (604) 875-4111, phoneExt: 21369, email: elise.abikhalil@ubc.ca, contacts name: Aline Talhouk, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, hasResults: False