Preserving Fertility After Colorectal Cancer Study

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05239338
• Lead Sponsor: Andreana Holowatyj, PhD, MSCI

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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study Start: 2021-12-06
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2036-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual health history (Questionnaire)	Baseline timepoint
Change(s) in reproductive health (Questionnaire)	Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Changes in sexual health (Questionnaire)	Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
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.
Disease-free survival	Up to 5 years
Reproductive health history (Questionnaire)	Baseline timepoint
Sexual health (Interview)	9 month post-treatment/Surveillance timepoint

Secondary Outcome Measures

Name	Time	Method
Change(s) in health-related quality of life (Questionnaire)	At baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Physical activity (Accelerometer)	36 month post-treatment/Surveillance timepoint

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States