[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457648":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":15,"overallOfficials":52,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":15,"id":83,"slug":15,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":15,"studyType":96,"phases":15,"briefSummary":97,"conditions":98,"keywords":15,"overallStatus":64,"whyStopped":15,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":15},[9,13,17,19,21,24,27],{"measure":10,"description":11,"timeFrame":12},"Change(s) in serum hormonal markers","For female patients not taking oral contraceptive pills (OCPs), serum hormonal markers to be measured include: anti-Mullerian hormone (AMH), estrogens, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and androgens. For male patients, serum hormonal markers to be measured include: inhibin B, FSH, androgens, estrogens, SHBG and LH.","Baseline, treatment and multiple surveillance timepoints (up to 5 years)",{"measure":14,"description":15,"timeFrame":16},"Reproductive health history (Questionnaire)",null,"Baseline timepoint",{"measure":18,"description":15,"timeFrame":12},"Change(s) in reproductive health (Questionnaire)",{"measure":20,"description":15,"timeFrame":16},"Sexual health history (Questionnaire)",{"measure":22,"description":15,"timeFrame":23},"Changes in sexual health (Questionnaire)","Baseline, treatment and multiple surveillance timepoints (Up to 5 years)",{"measure":25,"description":15,"timeFrame":26},"Sexual health (Interview)","9 month post-treatment\u002FSurveillance timepoint",{"measure":28,"description":15,"timeFrame":29},"Disease-free survival","Up to 5 years",[31,34,36,38,39,41],{"measure":32,"description":15,"timeFrame":33},"Change(s) in health-related quality of life (Questionnaire)","At baseline, treatment and multiple surveillance timepoints (Up to 5 years)",{"measure":35,"description":15,"timeFrame":16},"Physical activity (Accelerometer)",{"measure":35,"description":15,"timeFrame":37},"Completion of first-course treatment (or 9 months after baseline)",{"measure":35,"description":15,"timeFrame":26},{"measure":35,"description":15,"timeFrame":40},"18 month post-treatment\u002FSurveillance timepoint",{"measure":35,"description":15,"timeFrame":42},"36 month post-treatment\u002FSurveillance timepoint",{"allocation":15,"interventionModel":15,"interventionModelDescription":15,"primaryPurpose":15,"observationalModel":44,"timePerspective":45,"maskingInfo":15},"COHORT","PROSPECTIVE","The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years.\n\nPatients are recruited prior to colorectal cancer therapy \\[baseline\\] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy \\[treatment\\]); (ii) and at 9, 18 and 36 month intervals thereafter \\[surveillance\\]. This cohort is enriched by a robust collection of biospecimens and data.","Individuals diagnosed with colorectal cancer between the ages of 18 to 49 years.",[49],{"label":50,"type":15,"description":51,"interventionNames":15},"PREFACE: Vanderbilt-Ingram Cancer Center","Patient recruitment and follow-up, longitudinal collection of data and multiple biospecimen at pre-defined study timepoints, objective assessment of health behaviors\u002Fhabits, individual interviews.",[53],{"name":54,"affiliation":5,"role":55},"Andreana N Holowatyj, PhD, MSCI","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":15,"email":61},"PREFACE Study Coordinator (Rebecca B.)","CONTACT","615-936-6204","prefacestudy@vumc.org",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-86.78444,36.16589,{"lat":74,"lon":73},[77,78],{"name":58,"role":59,"phone":60,"phoneExt":15,"email":61},{"name":54,"role":55,"phone":15,"phoneExt":15,"email":15},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"SPONSOR_INVESTIGATOR","Andreana Holowatyj, PhD, MSCI","Sponsor Investigator","100457648",false,"NCT05239338","Preserving Fertility After Colorectal Cancer Study","Preserving Fertility After Colorectal Cancer: The PREFACE Study","PREFACE","Inclusion Criteria:\n\n* Known diagnosis of colorectal cancer\n* Age 18 to 49 years at colorectal cancer diagnosis\n* Diagnosed by and\u002For consulting with a physician participating in the PREFACE Study\n* No prior history of colorectal cancer and\u002For colorectal cancer treatment\n* Mentally and physically able to consent and participate in the study\n\nExclusion Criteria:\n\n* Women who are pregnant at the time of colorectal cancer diagnosis\n* Prisoners\n* Unable to provide informed consent\n* Unable to read, write, or complete questionnaires in English","ALL","18 Years","49 Years",{"count":94,"type":95},1000,"ESTIMATED","OBSERVATIONAL","The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.",[99],"Colorectal Cancer","2025-04-15",{"date":102,"type":103},"2025-04-18","ACTUAL",{"date":105,"type":103},"2021-12-06",{"date":107,"type":95},"2037-12",{"name":81,"class":6},1]