Assessment of Ovarian Reserve in Female Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
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: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Breast Cancer Survivor
Pediatric Cancer Survivor
Procedure: Blood Draw and Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the changes in ovarian function associated with specific chemotherapy regimens. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the time-to-pregnancy and cumulative incidence of pregnancy among young cancer survivors attempting pregnancy after treatment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast Cancer Survivors 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.
Pediatric Cancer Survivors 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.
Control group 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients are selected from their primary care clinic.

Criteria

Inclusion Criteria:

  • Breast Cancer Survivors

    1. histological confirmation of breast cancer
    2. received chemotherapy +/- radiotherapy with curative intent
    3. age 40 years or less at the time of diagnosis
    4. currently age 50 years or less
    5. currently disease free.
  • Pediatric Cancer Survivors

    1. Received chemotherapy and / or radiotherapy with curative intent.
    2. Currently age 18 years and older.
    3. Currently premenopausal and attained at age 50 years or less.
    4. Currently disease free.
    5. Diagnosed with sarcoma or Hodgkin's disease or leukemia at 30 years or less.
  • Control group 1. Premenopausal.

Exclusion Criteria:

  • Breast Cancer Survivors

    1. treatment for malignancy other than breast cancer, involving chemotherapy or radiation to the ovaries/pelvis.
    2. any cancer recurrence
    3. hysterectomy/oophorectomy.
  • Pediatric Cancer Survivors

    1. Hysterectomy / oophorectomy.
    2. Pelvic Radiation.
  • Control group

    1. Received chemotherapy and / or pelvic radiation therapy,
    2. hysterectomy/oophorectomy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062542

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01062542     History of Changes
Other Study ID Numbers: UHN REB 08-0115-B
Study First Received: January 21, 2010
Last Updated: June 24, 2014
Health Authority: Canada: Review Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014