Assessing Fertility Potential in Female Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Pennsylvania
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Clarisa Gracia, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01143844
First received: June 11, 2010
Last updated: July 22, 2013
Last verified: August 2012
  Purpose

Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy.

At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.


Condition
Effects of Chemotherapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing Fertility Potential in Female Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reproductive hormones [ Time Frame: Annually for 3-5 years ] [ Designated as safety issue: No ]
    Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).


Secondary Outcome Measures:
  • Antral Follicle Counts [ Time Frame: Annually for 3-5 years ] [ Designated as safety issue: No ]
    All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and >10 mm in diameter.


Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 400
Study Start Date: March 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females exposed to chemotherapy, ages 11-40
  • Prior exposure to alkylating agent chemotherapy and/or radiation therapy
  • At least 1 year from completion of chemotherapy and/or radiation therapy
  • Uterus and at least one ovary are present
  • Not pregnant or breastfeeding in the past 3 months
  • Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits
  • No medical condition (other than cancer) known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).
Unexposed females, ages 40-50
  • Never exposed to chemotherapy or radiation therapy
  • Regular menstrual cycle (every 21-35 days)
  • Uterus and at least one ovary are present
  • Not pregnant or breastfeeding in the past 3 months
  • Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits
  • No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).
Unexposed females, ages 11-35
  • Never exposed to chemotherapy or radiation therapy
  • Regular menstrual cycle (every 21-35 days)
  • Uterus and at least one ovary are present
  • Not pregnant or breastfeeding in the past 3 months
  • Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits
  • No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).

Detailed Description:

Up to 400 females will participate in this study in one of three cohorts:

  • 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy
  • 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy
  • 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
  Eligibility

Ages Eligible for Study:   11 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a history of cancer, or other conditions treated by chemotherapy, will be identified through local survivorship programs or self-referral. In addition, two groups of regularly menstruating unexposed subjects will be recruited through local advertising: a group of similar-age subjects and another group in the late reproductive years. Exposed and unexposed controls will be frequency matched with respect to age (within 2 years) at enrollment. In addition,subjects will be balanced with respect to self reported race/ethnicity. Enrollment is purposefully targeted and stratified for this study to reflect the population in the pediatric and adult oncology practices.

Criteria

Inclusion Criteria for cancer survivors:

  • Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness.
  • Age between 11-35 years.
  • Post-menarchal.
  • Presence of a uterus and at least one ovary.
  • Ability and willingness to comply with study protocol.
  • Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Inclusion Criteria for controls:

  • Healthy females who have never been treated for cancer.
  • Age between 11-35 and 40-50 years.
  • Post-menarchal with regular cyclic menses (every 21-35 days)
  • Presence of a uterus and at least 1 ovary.
  • Ability and willingness to comply with study protocol.
  • Have given written informed concent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Exclusion Criteria:

  • Current pregnancy.
  • Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks.
  • Lactation within the previous 3 months.
  • Chronic illness that would limit ability of participant to comply with study protocol.
  • Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).
  • For controls, a history of infertility.
  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: NCT01143844

Contacts
Contact: Lara Lechtenberg, BA 215-614-1414 lechtenl@uphs.upenn.edu; PennOncoFertility@uphs.upenn.edu

Locations
United States, Pennsylvania
Penn Reproductive Research Unit, 3701 Market Street, Suite 810 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vivian Conti    215-662-7727    PennOncoFertility@uphs.upenn.edu   
Principal Investigator: Clarisa Gracia, MD, MSCE         
Penn Medicine at Radnor, 250 King of Prussia Road Recruiting
Radnor, Pennsylvania, United States, 19087
Principal Investigator: Clarisa Gracia, MD, MSCE         
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Clarisa R Gracia, MD, MSCE University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Clarisa Gracia, Clarisa R. Gracia, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01143844     History of Changes
Other Study ID Numbers: 804237, UPCC12807
Study First Received: June 11, 2010
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
perimenopause
Oncofertility
Fertility
Late effects
cancer
chemotherapy
radiation therapy
survivor
ovarian reserve
premature ovarian failure
early menopause
healthy volunteers
middle age
pediatric survivors
healthy women

ClinicalTrials.gov processed this record on August 27, 2014