An observational study in Breast Cancer, sponsored by Lynn Henry. Completed at 1 site in United States. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by Lynn Henry · Observational
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries.
In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 28 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Lynn Henry is the lead sponsor of 4 studies on the registry; none are open to participants now.
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premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.
Inclusion Criteria:
Patients must have:
estimates of serum concentrations
To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy. Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy
Time frame: 1 year
serum concentrations of reproductive hormones
To determine serum concentrations of reproductive hormones (estradiol and its metabolites) before, immediately after, and 1 year following completion of chemotherapy using standard estradiol assays, and compare these results to those obtained using metabolomics. Hypothesis: Serum concentrations of reproductive hormones (estradiol and its metabolites) will be detectable in all premenopausal women before chemotherapy, and will decrease immediately after chemotherapy in a considerable subset of patients. In addition, metabolomics will provide the same information about the presence or absence of estrogens, and will also provide additional data about other compounds present in the serum. 2
Time frame: 1 year
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Lynn Henry