Assessment of Ovarian Reserve in Female Cancer Survivors

NCT ID: NCT01062542

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2018-03-02

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.

Conditions

Breast Cancer Survivor; Pediatric Cancer Survivor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer Survivors

Blood Draw and Ultrasound

Intervention Type: PROCEDURE

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

Blood Draw and Ultrasound

Intervention Type: PROCEDURE

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

Blood Draw and Ultrasound

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hodgson, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 08-0115-B

Identifier Type: -

Identifier Source: org_study_id