An observational study in Breast Cancer Survivor and Pediatric Cancer Survivor, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.
Sponsored by University Health Network, Toronto · Observational
Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. In this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. We will do the same tests in our comparison group. We can use these results to estimate the reduction in fertility in young cancer survivors.
As women across North America and Europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. The dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. The information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. A significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this.
This study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. The results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. The results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. Further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients are selected from their primary care clinic.
Breast Cancer Survivors
Pediatric Cancer Survivors
Exclusion Criteria:
Breast Cancer Survivors
Pediatric Cancer Survivors
Control group
Procedure: Blood Draw and Ultrasound
Procedure: Blood Draw and Ultrasound
Procedure: Blood Draw and Ultrasound
Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately.
To estimate the immediate decline in ovarian reserve in young breast cancer patients receiving chemotherapy using new biochemical and biophysical measures
Time frame: 3 years
To model the decline in ovarian reserve with advancing age after cancer therapy in both young breast cancer and childhood cancer survivors and compare this with the decline seen in controls
Time frame: 3 years
To develop methods to estimate the time to onset of menopause, and the time before natural or assisted conception such as in vitro fertilization become less successful
Time frame: 3 years
To evaluate the changes in ovarian function associated with specific chemotherapy regimens.
Time frame: 3 years
To determine the time-to-pregnancy and cumulative incidence of pregnancy among young cancer survivors attempting pregnancy after treatment.
Time frame: 3 years
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto