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PREFACE: Preserving Fertility After Colorectal Cancer Study

Sponsor
Andreana Holowatyj, PhD, MSCI (Other)
Overall Status
Recruiting
CT.gov ID
NCT05239338
Collaborator
(none)
1,000
Enrollment
1
Location
191.8
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Preserving Fertility After Colorectal Cancer: The PREFACE Study
    Actual Study Start Date :
    Dec 6, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2036
    Anticipated Study Completion Date :
    Dec 1, 2037

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change(s) in serum hormonal markers [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) [Baseline timepoint]

    3. Change(s) in reproductive health (Questionnaire) [Baseline, treatment and multiple surveillance timepoints (up to 5 years)]

    4. Sexual health history (Questionnaire) [Baseline timepoint]

    5. Changes in sexual health (Questionnaire) [Baseline, treatment and multiple surveillance timepoints (Up to 5 years)]

    6. Sexual health (Interview) [9 month post-treatment/Surveillance timepoint]

    7. Disease-free survival [Up to 5 years]

    Secondary Outcome Measures

    1. Change(s) in health-related quality of life (Questionnaire) [At baseline, treatment and multiple surveillance timepoints (Up to 5 years)]

    2. Physical activity (Accelerometer) [Baseline timepoint]

    3. Physical activity (Accelerometer) [Completion of first-course treatment (or 9 months after baseline)]

    4. Physical activity (Accelerometer) [9 month post-treatment/Surveillance timepoint]

    5. Physical activity (Accelerometer) [18 month post-treatment/Surveillance timepoint]

    6. Physical activity (Accelerometer) [36 month post-treatment/Surveillance timepoint]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Andreana Holowatyj, PhD, MSCI

    Investigators

    • Principal Investigator: Andreana N Holowatyj, PhD, MSCI, Vanderbilt-Ingram Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Andreana Holowatyj, PhD, MSCI, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05239338
    Other Study ID Numbers:
    • VICC GI 2186
    First Posted:
    Feb 14, 2022
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Feb 14, 2022