Ovarian Cancer Clinical Trial

Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor

Summary

This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy on ovarian reserve and fertility in patients with chronic myeloid leukemia or gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.

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Full Description

PRIMARY OBJECTIVES:

I. To collect preliminary information to help design a study to look at longitudinal changes in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine kinase inhibitors (TKI) therapy.

SECONDARY OBJECTIVES:

I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo in vitro fertilization (IVF) for fertility preservation.

OUTLINE:

Patients undergo transvaginal ultrasound for antral follicles analysis and collection of serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and 48 weeks.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), non metastatic cancer where TKI is the first line agent
Premenopausal (has had menses at any time in the preceding 12 consecutive months)
Has not undergone a hysterectomy or bilateral oophorectomy
Willing to use non-hormonal (ie: barrier method or abstinence) as form of contraception during the one year of study

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy in the past
Patients may not be receiving any other investigational agents
Patients must not be pregnant or nursing
Other medical conditions or treatments that affect hormonal levels (potentially confounding interpretation of results)
Patients with ongoing hormonal contraception or unwilling or unable to discontinue will not eligible

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

20

Study ID:

NCT02734823

Recruitment Status:

Recruiting

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Irene Woo
Contact
323-226-2850
[email protected]
Irene Woo
Principal Investigator

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

20

Study ID:

NCT02734823

Recruitment Status:

Recruiting

Sponsor:


University of Southern California

How clear is this clinincal trial information?

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