Preserving Fertility After Colorectal Cancer Study (PREFACE)

Andreana Holowatyj, PhD, MSCI

Status: Enrolling

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05239338

VICC GI 2186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

PREFACE: Vanderbilt-Ingram Cancer Center

Description:

Patient recruitment and follow-up, longitudinal collection of data and multiple biospecimen at pre-defined study timepoints, objective assessment of health behaviors/habits, individual interviews.