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Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve


N/A
18 Years
50 Years
Open (Enrolling)
Female
Breast Cancer Survivor, Pediatric Cancer Survivor

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Trial Information

Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

David Hodgson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Review Ethics Committee

Study ID:

UHN REB 08-0115-B

NCT ID:

NCT01062542

Start Date:

September 2008

Completion Date:

September 2015

Related Keywords:

  • Breast Cancer Survivor
  • Pediatric Cancer Survivor
  • Breast Neoplasms

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