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NCT01197456 · ClinicalTrials.gov registry record
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
A clinical trial, sponsored by University of California, San Diego.
- Completed
- Registry status
- 232
- Enrollment target
NCT01197456: Completed study, sponsored by University of California, San Diego.
NCT01197456 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 232 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197456 has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 232 participants
- Enrollment target
Study Summary
More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options. The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.
Primary Outcome
Number of participant without of menses for 12 months after breast cancer diagnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2008-09-24 |
| Est. Completion | 2019-07-18 |
What the finished NCT01197456 record still lists
NCT01197456 is an observational study that tracks outcomes without assigning an intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01197456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197456 about?
NCT01197456 is a clinical study titled "Predictors of Ovarian Insufficiency in Young Breast Cancer Patients". More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis...
What is the current status of trial NCT01197456?
This trial is currently completed. The enrollment target is 232 participants. The study started on 2008-09-24. Estimated completion is 2019-07-18.
Who is sponsoring clinical trial NCT01197456?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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