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Recruiting

NCT Number: NCT05239338

Preserving Fertility After Colorectal Cancer Study

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.

Recruiting

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Andreana N Holowatyj, PhD, MSCI

PRINCIPAL_INVESTIGATOR

PREFACE Study Coordinator (Rebecca B.)

CONTACT

[email protected]

615-936-6204

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change(s) in serum hormonal markers

    Time frame: 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.

  2. Reproductive health history (Questionnaire)

    Time frame: Baseline timepoint

  3. Change(s) in reproductive health (Questionnaire)

    Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)

  4. Sexual health history (Questionnaire)

    Time frame: Baseline timepoint

  5. Changes in sexual health (Questionnaire)

    Time frame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)

  6. Sexual health (Interview)

    Time frame: 9 month post-treatment/Surveillance timepoint

  7. Disease-free survival

    Time frame: Up to 5 years

Secondary outcomes

  1. Change(s) in health-related quality of life (Questionnaire)

    Time frame: At baseline, treatment and multiple surveillance timepoints (Up to 5 years)

  2. Physical activity (Accelerometer)

    Time frame: Baseline timepoint

  3. Physical activity (Accelerometer)

    Time frame: Completion of first-course treatment (or 9 months after baseline)

  4. Physical activity (Accelerometer)

    Time frame: 9 month post-treatment/Surveillance timepoint

  5. Physical activity (Accelerometer)

    Time frame: 18 month post-treatment/Surveillance timepoint

  6. Physical activity (Accelerometer)

    Time frame: 36 month post-treatment/Surveillance timepoint

Study contacts

Contact information is provided by the study sponsor or research team.

PREFACE Study Coordinator (Rebecca B.)

CONTACT

[email protected]

615-936-6204

Sponsors and collaborators

Lead sponsor

Andreana Holowatyj, PhD, MSCI

Other

Registry information

Official study title

Preserving Fertility After Colorectal Cancer: The PREFACE Study

Acronym: PREFACE

Important dates

Study start
2021
Primary completion
2036
Study completion
2037
First posted
Feb 14, 2022
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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