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Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations

NCT00823654 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 609

Last updated 2025-10-14

No results posted yet for this study

Summary

The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.

Conditions

Interventions

OTHER

Blood draw and questionnaires

Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive health questionnaire (Appendix A)/menstrual calendar (Appendix C) / sexual health questionnaires (Appendices E, F, G) ↓ Start planned therapy (or observation) ↓ Evaluation at completion of chemotherapy Blood draw and collection of monthly menstrual calendars ↓ One year post chemo Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) ↓ Annual follow-up x 3 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) )/ sexual health questionnaires (Appendices E, F, G)

OTHER

Blood draw and questionnaires

Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive and sexual health questionnaires (Appendices A, E, F, G)/menstrual calendar (Appendix C) ↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G) ↓ Annual follow-up years x 3 if feasible Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G)

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • New York Presbyterian Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Shari Goldfarb, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823654 on ClinicalTrials.gov