Clinical trial NCT05239338: Preserving Fertility After Colorectal Cancer Study
Official title: Preserving Fertility After Colorectal Cancer: The PREFACE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with colorectal cancer between the ages of 18 to 49 years.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change(s) in serum hormonal markers
timeFrame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
measure: Reproductive health history (Questionnaire)
timeFrame: Baseline timepoint
measure: Change(s) in reproductive health (Questionnaire)
timeFrame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
measure: Sexual health history (Questionnaire)
timeFrame: Baseline timepoint
measure: Changes in sexual health (Questionnaire)
timeFrame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
measure: Sexual health (Interview)
timeFrame: 9 month post-treatment/Surveillance timepoint
measure: Disease-free survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Change(s) in health-related quality of life (Questionnaire)
timeFrame: At baseline, treatment and multiple surveillance timepoints (Up to 5 years)
measure: Physical activity (Accelerometer)
timeFrame: Baseline timepoint
measure: Physical activity (Accelerometer)
timeFrame: Completion of first-course treatment (or 9 months after baseline)
measure: Physical activity (Accelerometer)
timeFrame: 9 month post-treatment/Surveillance timepoint
measure: Physical activity (Accelerometer)
timeFrame: 18 month post-treatment/Surveillance timepoint
measure: Physical activity (Accelerometer)
timeFrame: 36 month post-treatment/Surveillance timepoint
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Andreana N Holowatyj, PhD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holowatyj AN, Eng C, Lewis MA. Incorporating Reproductive Health in the Clinical Management of Early-Onset Colorectal Cancer. JCO Oncol Pract. 2022 Mar;18(3):169-172. doi: 10.1200/OP.21.00525. Epub 2021 Sep 23. No abstract available.
citation: Eng C, Jacome AA, Agarwal R, Hayat MH, Byndloss MX, Holowatyj AN, Bailey C, Lieu CH. A comprehensive framework for early-onset colorectal cancer research. Lancet Oncol. 2022 Mar;23(3):e116-e128. doi: 10.1016/S1470-2045(21)00588-X. Epub 2022 Jan 31.
citation: Keller SR, Rosen A, Lewis MA, Park HK, Babyak R, Feldman J, Ye F, Agarwal R, Ciombor KK, Geiger TM, Eng C, Hunzinger KJ, Viskochil RH, Roach MK, Velez Edwards DR, Cote ML, Holowatyj AN. Patient-Reported Discussions on Fertility Preservation Before Early-Onset Cancer Treatment. JAMA Netw Open. 2024 Nov 4;7(11):e2444540. doi: 10.1001/jamanetworkopen.2024.44540.