Study on preserving fertility in young adults with colorectal cancer
Preserving Fertility After Colorectal Cancer: The PREFACE Study
This study is testing how colorectal cancer and its treatments affect fertility and sexual health in young adults aged 18 to 49.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05239338 on ClinicalTrials.gov |
What this trial studies
The Preserving Fertility After Colorectal Cancer (PREFACE) Study is a prospective, longitudinal cohort investigation focusing on reproductive health and clinical outcomes for individuals aged 18 to 49 diagnosed with colorectal cancer. Participants are recruited before starting cancer treatment and are followed for up to 36 months post-treatment completion. The study includes regular assessments at defined intervals and collects a variety of biospecimens and data to understand the impact of colorectal cancer on fertility and sexual health. This comprehensive approach aims to provide insights into the long-term effects of cancer treatment on reproductive health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 49 who have been diagnosed with colorectal cancer and are consulting with a participating physician.
Not a fit: Patients who are pregnant at the time of diagnosis or those with a prior history of colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information to help preserve fertility in young adults diagnosed with colorectal cancer.
How similar studies have performed: While there have been studies focusing on fertility preservation in cancer patients, this specific approach targeting colorectal cancer in young adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Andreana N Holowatyj, PhD, MSCI — Vanderbilt-Ingram Cancer Center
- Study coordinator: PREFACE Study Coordinator (Rebecca B.)
- Email: prefacestudy@vumc.org
- Phone: 615-936-6204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.