Clinical trial NCT01143844: Assessing Fertility Potential in Female Cancer Survivors
Official title: Assessing Fertility Potential in Female Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effects of Chemotherapy
Keywords: Oncofertility
Fertility
Late effects
cancer
chemotherapy
radiation therapy
survivor
ovarian reserve
premature ovarian failure
early menopause
healthy volunteers
perimenopause
middle age
pediatric survivors
healthy women
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2010-06-14
Enrollment: 391
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Reproductive hormones
timeFrame: Annually for 3-5 years
Secondary outcomes:
measure: Antral Follicle Counts
timeFrame: Annually for 3-5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Reproductive Research Unit, 3701 Market Street, Suite 810
state: Pennsylvania
city: Radnor
country: United States
facility: Penn Medicine at Radnor, 250 King of Prussia Road
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Clarisa R Gracia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gracia CR, Sammel MD, Freeman E, Prewitt M, Carlson C, Ray A, Vance A, Ginsberg JP. Impact of cancer therapies on ovarian reserve. Fertil Steril. 2012 Jan;97(1):134-40.e1. doi: 10.1016/j.fertnstert.2011.10.040. Epub 2011 Dec 2.