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Assessment of Ovarian Reserve in Female Cancer Survivors
This study is ongoing, but not recruiting participants.
Sponsor:
University Health Network, Toronto
Collaborators:
Princess Margaret Hospital, Canada
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062542
First received: January 21, 2010
Last updated: October 31, 2016
Last verified: October 2016
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 21, 2010 | |||
| Last Updated Date | October 31, 2016 | |||
| Start Date ICMJE | September 2008 | |||
| Estimated Primary Completion Date | April 2017 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01062542 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Assessment of Ovarian Reserve in Female Cancer Survivors | |||
| Official Title ICMJE | 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. |
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| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| 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 ICMJE |
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| Intervention ICMJE | 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. |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Active, not recruiting | |||
| Estimated Enrollment ICMJE | 210 | |||
| Estimated Completion Date | April 2017 | |||
| Estimated Primary Completion Date | April 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 50 Years (Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01062542 | |||
| Other Study ID Numbers ICMJE | 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 ICMJE | University Health Network, Toronto | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University Health Network, Toronto | |||
| Verification Date | October 2016 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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