RECRUITING

Evaluating a New Gonadotoxic Risk Stratification System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating a New Gonadotoxic Risk Stratification System

Quick Facts

Study Start:2024-04-01
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05052632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 39 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patients ages 8 - 39 years of age
  2. * Seen in CHCO or AMC outpatient clinics for any of the following reasons:
  3. * At risk for fertility problems (Z91.89)
  4. * Encounter for fertility preservation counseling (Z31.62)
  5. * Primary ovarian insufficiency
  6. * Premature ovarian failure/premature menopause
  7. * Diminished ovarian reserve
  8. * At least 12 months post-completion of chemotherapy and/or radiation
  9. * History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to:
  10. * Any type of cancer/malignancy
  11. * Rheumatoid arthritis
  12. * Systemic lupus erythematosus
  13. * Aplastic anemia
  14. * Fanconi anemia
  15. * Diamond-Blackfan syndrome
  16. * Hurler syndrome
  17. * Other autoimmune conditions
  1. * Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.)
  2. * History of bilateral oophorectomy
  3. * Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy
  4. * Inability to consent/assent

Contacts and Locations

Study Contact

Hadley Kelly, MPH
CONTACT
4135371818
hadley.kelly@cuanschutz.edu

Principal Investigator

Leslie Appiah, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado
Denver, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Leslie Appiah, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • ovarian reserve

Additional Relevant MeSH Terms

  • Cancer