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

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT02734823
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
96
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration
  • Procedure: Ultrasonography

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
Actual Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Cytology Specimen Collection Procedure
Undergo collection of serum
Other Names:
  • Cytologic Sampling

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Ancillary studies

    Procedure: Ultrasonography
    Undergo transvaginal pelvic ultrasonography
    Other Names:
  • ULTRASOUND
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Irene Woo, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT02734823
    Other Study ID Numbers:
    • 0S-15-7
    • NCI-2016-00352
    • 0S-15-7
    • P30CA014089
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Gastrointestinal Stromal Tumors

    Study Results

    No Results Posted as of Nov 18, 2021