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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 : Recruiting
First Posted : April 12, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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
Chronic Myelogenous Leukemia, BCR-ABL1 Positive Gastrointestinal Stromal Tumor Premenopausal Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Other: Questionnaire Administration Procedure: Ultrasonography

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.


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Study Type : Observational
Estimated 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 : March 1, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021


Group/Cohort 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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Serum


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734823


Contacts
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Contact: Irene Woo, MD 323-226-2850 Irene.woo@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Irene Woo    323-226-2850    Irene.woo@med.usc.edu   
Principal Investigator: Irene Woo         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Irene Woo University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02734823     History of Changes
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 )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Digestive System Diseases