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Trial record 13 of 13 for:    Recruiting, Not yet recruiting, Available Studies | "Premenopause"

Assessing Fertility Potential in Female Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01143844
Recruitment Status : Recruiting
First Posted : June 14, 2010
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease
Effects of Chemotherapy

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

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing Fertility Potential in Female Cancer Survivors
Study Start Date : March 2006
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Exposed females, 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).



Primary Outcome Measures :
  1. Reproductive hormones [ Time Frame: Annually for 3-5 years ]
    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 :
  1. Antral Follicle Counts [ Time Frame: Annually for 3-5 years ]
    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


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Ages Eligible for Study:   11 Years to 50 Years   (Child, Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143844


Contacts
Contact: Maureen Prewitt, BSN 215-614-1414 prewittm@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: Allison Schanne, BS    215-614-1414    Allison.Schanne@uphs.upenn.edu; 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
Contact: Maureen Prewitt, BSN    215-614-1414    prewittm@uphs.upenn.edu; PennOncofertility@uphs.upenn.edu   
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

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01143844     History of Changes
Other Study ID Numbers: 804237
UPCC12807 ( Other Identifier: University of Pennsylvania Abramson Cancer Center )
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.

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