Assessment of Ovarian Reserve in Female Cancer Survivors

Tracking Information
First Submitted Date	January 21, 2010
First Posted Date	February 4, 2010
Last Update Posted Date	June 12, 2018
Study Start Date	September 2008
Actual Primary Completion Date	March 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 3, 2010)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01062542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: February 3, 2010)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Assessment of Ovarian Reserve in Female Cancer Survivors
Official Title	Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve
Brief Summary	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.
Detailed Description	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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients are selected from their primary care clinic.
Condition	Breast Cancer Survivor; Pediatric Cancer Survivor
Intervention	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.
Study Groups/Cohorts	Breast Cancer Survivors Intervention: Procedure: Blood Draw and Ultrasound; Pediatric Cancer Survivors Intervention: Procedure: Blood Draw and Ultrasound; Control group Intervention: Procedure: Blood Draw and Ultrasound
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: February 3, 2010)	210
Original Estimated Enrollment	Same as current
Actual Study Completion Date	March 2, 2018
Actual Primary Completion Date	March 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Breast Cancer Survivors histological confirmation of breast cancer received chemotherapy +/- radiotherapy with curative intent age 40 years or less at the time of diagnosis currently age 50 years or less currently disease free.; Pediatric Cancer Survivors Received chemotherapy and / or radiotherapy with curative intent. Currently age 18 years and older. Currently premenopausal and attained at age 50 years or less. Currently disease free. Diagnosed with sarcoma or Hodgkin's disease or leukemia at 30 years or less.; Control group 1. Premenopausal. Exclusion Criteria: Breast Cancer Survivors treatment for malignancy other than breast cancer, involving chemotherapy or radiation to the ovaries/pelvis. any cancer recurrence hysterectomy/oophorectomy.; Pediatric Cancer Survivors Hysterectomy / oophorectomy. Pelvic Radiation.; Control group Received chemotherapy and / or pelvic radiation therapy, hysterectomy/oophorectomy.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Canada
Removed Location Countries
Administrative Information
NCT Number	NCT01062542
Other Study ID Numbers	UHN REB 08-0115-B
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University Health Network, Toronto
Study Sponsor	University Health Network, Toronto
Collaborators	Princess Margaret Hospital, Canada; Canadian Breast Cancer Foundation
Investigators	Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
PRS Account	University Health Network, Toronto
Verification Date	June 2018