Colorectal Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Andreana Holowatyj, PhD, MSCI
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Known diagnosis of colorectal cancer * Age 18 to 49 years at colorectal cancer diagnosis * Diagnosed by and/or consulting with a physician participating in the PREFACE Study * No prior history of colorectal cancer and/or colorectal cancer treatment * Mentally and physically able to consent and participate in the study
Exclusion criteria
* Women who are pregnant at the time of colorectal cancer diagnosis * Prisoners * Unable to provide informed consent * Unable to read, write, or complete questionnaires in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | Up to 5 years | — |
| Changes in sexual health (Questionnaire) | Baseline, treatment and multiple surveillance timepoints (Up to 5 years) | — |
| Sexual health (Interview) | 9 month post-treatment/Surveillance timepoint | — |
| Change(s) in serum hormonal markers | Baseline, treatment and multiple surveillance timepoints (up to 5 years) | 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. |
| Reproductive health history (Questionnaire) | Baseline timepoint | — |
| Change(s) in reproductive health (Questionnaire) | Baseline, treatment and multiple surveillance timepoints (up to 5 years) | — |
| Sexual health history (Questionnaire) | Baseline timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity (Accelerometer) | Baseline timepoint |
| Change(s) in health-related quality of life (Questionnaire) | At baseline, treatment and multiple surveillance timepoints (Up to 5 years) |
Countries
United States
Contacts
Primary ContactPREFACE Study Coordinator (Rebecca B.)
Outcome results
None listed