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.
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. Patients 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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGChange(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.
Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Reproductive health history (Questionnaire)
Time frame: Baseline timepoint
Change(s) in reproductive health (Questionnaire)
Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Sexual health history (Questionnaire)
Time frame: Baseline timepoint
Changes in sexual health (Questionnaire)
Time frame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Sexual health (Interview)
Time frame: 9 month post-treatment/Surveillance timepoint
Disease-free survival
Time frame: Up to 5 years
Change(s) in health-related quality of life (Questionnaire)
Time frame: At baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Physical activity (Accelerometer)
Time frame: Baseline timepoint
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Physical activity (Accelerometer)
Time frame: Completion of first-course treatment (or 9 months after baseline)
Physical activity (Accelerometer)
Time frame: 9 month post-treatment/Surveillance timepoint
Physical activity (Accelerometer)
Time frame: 18 month post-treatment/Surveillance timepoint
Physical activity (Accelerometer)
Time frame: 36 month post-treatment/Surveillance timepoint