A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00644683
First received: January 17, 2008
Last updated: December 18, 2012
Last verified: December 2012

January 17, 2008
December 18, 2012
September 2007
December 2014   (final data collection date for primary outcome measure)
estimates of serum concentrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

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Complete list of historical versions of study NCT00644683 on ClinicalTrials.gov Archive Site
serum concentrations of reproductive hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

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A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

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.

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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
  • Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
  • Patients must have:

    • Reached their 25th birthday and not yet reached their 51st birthday at the time of study enrollment, AND
    • Had menses within 3 months prior to starting chemotherapy
  • Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
  • Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
  • ECOG performance status 0 - 2
  • Pregnant or nursing women may not participate. Women of reproductive potential must agree to use an effective non-hormonal contraceptive method, such as condoms, tubal ligation, non-hormonal intrauterine device, partner sterilization, and abstinence during chemotherapy.
  • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Female
25 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00644683
UMCC 2007.081, HUM 00014246
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Norah L Henry, MD, PhD University of Michigan
University of Michigan Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP