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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

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ClinicalTrials.gov Identifier: NCT02734823
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : April 12, 2016
Last Update Posted : March 18, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date April 6, 2016
First Posted Date April 12, 2016
Last Update Posted Date March 18, 2024
Actual Study Start Date March 1, 2016
Estimated Primary Completion Date March 14, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2016)		 Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 6, 2016)		 Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation [ Time Frame: Up to 1 year ]
The results of their stimulation protocol will be recorded.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor
Official Title Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.
Condition
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Gastrointestinal Stromal Tumor
  • Premenopausal
Intervention
  • Other: Cytology Specimen Collection Procedure
    Undergo collection of serum
    Other Name: 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
Study Groups/Cohorts 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.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration
  • Procedure: Ultrasonography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 14, 2024)		 0
Original Estimated Enrollment
 (submitted: April 6, 2016)		 20
Estimated Study Completion Date March 14, 2024
Estimated Primary Completion Date March 14, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02734823
Other Study ID Numbers 0S-15-7
NCI-2016-00352 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-15-7 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of Southern California
Original Responsible Party Same as current
Current Study Sponsor University of Southern California
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Irene Woo University of Southern California
PRS Account University of Southern California
Verification Date March 2024