Philadelphia, Pennsylvania 19104


Purpose:

Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.


Study summary:

A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment. Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.


Criteria:

Inclusion Criteria for exposed population: - Postmenarchal females to be treated with chemotherapy - between the ages of 11-35 years, - with a uterus and at least one ovary Inclusion Criteria for unexposed population: - healthy postmenarchal females - no prior or planned exposure to chemotherapy - between the ages of 11-35, - with a uterus and at least one ovary - regular menstrual cycles (21-35 days) Exclusion criteria for all subjects: - positive pregnancy test at enrollment - lactation within the previous 1 month, - previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer. - previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) - endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia). Additional exclusions for the unexposed population: - a history of infertility, defined as at least 12 months of unprotected intercourse without conception - polycystic ovary syndrome (PCOS)


NCT ID:

NCT02467231


Primary Contact:

Principal Investigator
Clarisa R Gracia, MD, MSCE
University of Pennsylvania

Maureen Prewitt, BSN, RN
Phone: 215-614-1414
Email: prewittm@uphs.upenn.edu


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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