Assessment of Ovarian Reserve in Female Cancer Survivors

NCT01062542 | Completed

• 1 other identifier: UHN REB 08-0115-B
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivor; Pediatric Cancer Survivor

Outcome Measures

Primary Outcomes (3)

• To estimate the immediate decline in ovarian reserve in young breast cancer patients receiving chemotherapy using new biochemical and biophysical measures

  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

  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

  3 years

Secondary Outcomes (2)

• To evaluate the changes in ovarian function associated with specific chemotherapy regimens.

  3 years

• To determine the time-to-pregnancy and cumulative incidence of pregnancy among young cancer survivors attempting pregnancy after treatment.

  3 years

Study Arms (3)

Breast Cancer Survivors

Procedure: Blood Draw and Ultrasound

Pediatric Cancer Survivors

Procedure: Blood Draw and Ultrasound

Control group

Procedure: Blood Draw and Ultrasound

Interventions

Blood Draw and Ultrasound 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.

Breast Cancer Survivors; Control group; Pediatric Cancer Survivors

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients are selected from their primary care clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Blood Specimen Collection; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• David Hodgson, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: February 4, 2010
• Study Start: September 1, 2008
• Primary Completion: March 1, 2018
• Study Completion: March 2, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

CA (1)