CancerNCT05052632
Evaluating a New Gonadotoxic Risk Stratification System
An observational study of Cancer, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 39 years, women only
- Conditions the study is for
- Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 5 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- ovarian reserve
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Apr 2024
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Why it stopped: Cancelled by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Appiah, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052632
- Sponsor's protocol ID
- 21-3084
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a New Gonadotoxic Risk Stratification System
- ClinicalTrials.gov ID
- NCT05052632
- Acronym / sponsor ID
- 21-3084
- Conditions
- Cancer
- Keywords
- ovarian reserve
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Cancelled by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (17 listed)
- Female patients ages 8 - 39 years of age
- Seen in CHCO or AMC outpatient clinics for any of the following reasons:
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovarian reserve
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Appiah, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian reserve (time frame: 2 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.