Recruiting

Fertility Preservation

Sponsor:

Andreana Holowatyj, PhD, MSCI

Code:

NCT05239338

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Colorectal Cancer

Study ID

NCT05239338

Start date

Dec 6, 2021

Status verified date

Apr, 2025

Completion date

Dec, 2037

Anticipated

Primary completion date

Dec, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

PREFACE: Vanderbilt-Ingram Cancer Center

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.

Primary outcome measure

  • Change(s) in serum hormonal markers [ Time Frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years) ]
  • Reproductive health history (Questionnaire) [ Time Frame: Baseline timepoint ]
  • Change(s) in reproductive health (Questionnaire) [ Time Frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years) ]
  • Sexual health history (Questionnaire) [ Time Frame: Baseline timepoint ]
  • Changes in sexual health (Questionnaire) [ Time Frame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years) ]
  • Sexual health (Interview) [ Time Frame: 9 month post-treatment/Surveillance timepoint ]
  • Disease-free survival [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

PREFACE Study Coordinator (Rebecca B.)

615-936-6204prefacestudy@vumc.org

Locations

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

PREFACE Study Coordinator (Rebecca B.)

615-936-6204prefacestudy@vumc.org

Principal Investigator:

Andreana N Holowatyj, PhD, MSCI

More Information

Sponsor

Andreana Holowatyj, PhD, MSCI

Last update posted

Apr 18, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andreana Holowatyj, PhD, MSCI on 2025-04-18.