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PREFACE Study: Fertility After Colorectal Cancer

The PREFACE Study is looking at how colorectal cancer and its treatments affect fertility and sexual health in young adults. This study doesn't test a new drug or treatment; instead, it observes people diagnosed with colorectal cancer between ages 18 and 49. Researchers will collect information through questionnaires and blood tests (to measure hormone levels) at different times over five years. The goal is to understand changes in reproductive health before, during, and after cancer treatment. You can join if you have a known diagnosis of colorectal cancer, are between 18 and 49 years old, and haven't had prior colorectal cancer treatment. The study is currently ongoing, but its exact status for new participants is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information from 1000 participants over time without giving them a specific intervention.
What's involved
You would complete questionnaires and have blood tests at the start, during treatment, and then at multiple follow-up times for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after diagnosis, with specific check-ins after treatment and at 9, 18, and 36 months.

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NCT05239338

Preserving Fertility After Colorectal Cancer Study

Recruiting
Not specifiedAges 18–49Observational
Andreana Holowatyj, PhD, MSCI
~1,000 participants
Updated 2025-04-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change(s) in serum hormonal markers
Measured over Baseline, treatment and multiple surveillance timepoints (up to 5 years)
+6 more outcomes measured

Conditions

Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Andreana N Holowatyj, PhD, MSCI · PRINCIPAL_INVESTIGATOR · Vanderbilt-Ingram Cancer Center

Who to contact

PREFACE Study Coordinator (Rebecca B.)
[email protected]
615-936-6204
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change(s) in serum hormonal markersBaseline, 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.

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