Clinical trial NCT05052632: Evaluating a New Gonadotoxic Risk Stratification System
Official title: Evaluating a New Gonadotoxic Risk Stratification System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: ovarian reserve
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 16690
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ovarian reserve
timeFrame: 2 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Appiah, MD
role: PRINCIPAL_INVESTIGATOR
References: