Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor
NCT ID: NCT02734823
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2016-03-01
2024-03-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (ovary imaging, hormonal analysis)
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.
Cytology Specimen Collection Procedure
Undergo collection of serum
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Ultrasonography
Undergo transvaginal pelvic ultrasonography
Interventions
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Cytology Specimen Collection Procedure
Undergo collection of serum
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Ultrasonography
Undergo transvaginal pelvic ultrasonography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Irene Woo
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2016-00352
Identifier Type: REGISTRY
Identifier Source: secondary_id
0S-15-7
Identifier Type: OTHER
Identifier Source: secondary_id
0S-15-7
Identifier Type: -
Identifier Source: org_study_id
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