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Evaluating a New Gonadotoxic Risk Stratification System

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05052632
Collaborator
(none)
16,690
Enrollment
73
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess if there is an association between a newly described gonadotoxic risk stratification system and post-treatment ovarian reserve as determined by FSH and AMH.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Investigator will test the amount of agreement between the two ordinal variables using a kappa statistic at each time point in the first two years of follow up. The Investigator will perform ordinal logistic regression accounting for repeated measures data for participants who are not using contraception. The Investigator will assess participant characteristics to see if the Investigator need to adjust for other covariates including age, race, ethnicity and body mass index (BMI).

    Since contraception can mask an elevated FSH surge from gonadal failure, the Investigator will perform a similar model for participants on contraception using AMH only.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    16690 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluating a New Gonadotoxic Risk Stratification System
    Anticipated Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2027
    Anticipated Study Completion Date :
    May 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Ovarian reserve [2 year follow up]

      The Investigator will evaluate if there is an association between ovarian reserve (defined using AMH and FSH) and the risk stratification system categories (minimally increased risk, significantly increased risk, and high level of increased risk). Specifically Ovarian reserve goes from normal ([FSH <10] AND [AMH >= 1.0]), Diminished ovarian reserve ([10 <=FSH < 25] or [ 0.5 <= AMH <1.0]), primary ovarian insufficiency ([25<= FSH] or [ 0.5 < AMH]). AMH: ng/ml, FSH: mIU/ml. Investigator will test the amount of agreement between the two ordinal variables using a kappa statistic at each time point in the first two years of follow-up. Investigator will perform ordinal logistic regression accounting for repeated measures for participants who are not using contraception. Investigator will access patient characteristics to see if Investigator need to adjust for other covariates including age, race, ethnicity, and body mass index.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female patients ages 8 - 39 years of age

    • Seen in CHCO or AMC outpatient clinics for any of the following reasons:

    • At risk for fertility problems (Z91.89)

    • Encounter for fertility preservation counseling (Z31.62)

    • Primary ovarian insufficiency

    • Premature ovarian failure/premature menopause

    • Diminished ovarian reserve

    • At least 12 months post-completion of chemotherapy and/or radiation

    • History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to:

    • Any type of cancer/malignancy

    • Rheumatoid arthritis

    • Systemic lupus erythematosus

    • Aplastic anemia

    • Fanconi anemia

    • Diamond-Blackfan syndrome

    • Hurler syndrome

    • Other autoimmune conditions

    Exclusion Criteria:

    • Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.)

    • History of bilateral oophorectomy

    • Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy

    • Inability to consent/assent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Leslie Appiah, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05052632
    Other Study ID Numbers:
    • 21-3084
    First Posted:
    Sep 22, 2021
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 11, 2022