Evaluating a new system to assess fertility risks in young cancer survivors
Evaluating a New Gonadotoxic Risk Stratification System
University of Colorado, Denver · NCT05052632
This study is testing a new system to see how well it can predict fertility risks in young women who have survived cancer treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16690 (estimated) |
| Ages | 8 Years to 39 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05052632 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a newly developed gonadotoxic risk stratification system and its correlation with post-treatment ovarian reserve, measured by FSH and AMH levels. The study will analyze the agreement between these two variables over the first two years following treatment, using statistical methods such as kappa statistics and ordinal logistic regression. Participants will include female patients aged 8 to 39 who are at risk for fertility issues due to cancer treatments. The study will also consider various participant characteristics, including age, race, ethnicity, and BMI, to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 8 to 39 who have completed cancer treatment and are at risk for fertility problems.
Not a fit: Patients with disorders of sexual development or those who have undergone bilateral oophorectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a better understanding of fertility risks in young cancer survivors, leading to improved fertility preservation strategies.
How similar studies have performed: While similar studies have explored fertility risks in cancer survivors, this specific approach using a new risk stratification system is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- University of Colorado — Denver, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Leslie Appiah, MD — University of Colorado, Denver
- Study coordinator: Hadley Kelly, MPH
- Email: hadley.kelly@cuanschutz.edu
- Phone: 4135371818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, ovarian reserve