Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor, Premenopausal
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERCytology Specimen Collection Procedure
Undergo collection of serum
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREUltrasonography
Undergo transvaginal pelvic ultrasonography
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer | Baseline to up to 1 year | Standard descriptive statistics and scatter plots will be used to summarize patterns by cohorts at each time point. Regression methods will be used to render data compatible with the assumption of the normal distribution. Analysis will be undertaken to obtain preliminary estimates of ovarian reserve over time and to elucidate whether TKI therapy produces a clinically meaningful change in ovarian reserve marker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation | Up to 1 year | The results of their stimulation protocol will be recorded. |
Countries
United States
Outcome results
None listed