Evaluating a New Gonadotoxic Risk Stratification System

Recruiting

• Conditions: Cancer

• Registration Number: NCT05052632
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 16690

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Denver, Colorado, United States