Evaluating a New Gonadotoxic Risk Stratification System

NCT05052632 | Withdrawn

• 1 other identifier: 21-3084
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve

  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.

  2 year follow up

Eligibility Criteria

• Age: 8 Years - 39 Years
• Gender Eligibility Details: In this study the Investigator is looking at Ovarian reserve and only female population will be included.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be prepubertal (8-12 years) and post-pubertal (13-39) females seen at the University of Colorado Anschutz Pavilion and/or Children's Hospital Colorado who have received gonadotoxic chemotherapy; radiation; or surgical excision of a reproductive organ for malignancy. The study participants will be assessed based on whether they are pre- or post-pubertal and then further stratified by age \< 25 years and \> 25 years based on the expected age-related decline of AMH.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Leslie Appiah, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: April 1, 2024
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08