NCT05239338 · Andreana Holowatyj, PhD, MSCI
Preserving Fertility After Colorectal Cancer Study
(PREFACE)
What this study is about
The PREFACE Study is a forward-looking, longitudinal group of participants study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.
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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.
Primary outcome measures
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Unable to provide informed consent
- Unable to read, write, or complete questionnaires in English
Where
- Nashville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 18, 2025 · Source of record for eligibility and locations