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

NCT02734823 | Withdrawn DMC

• 3 other identifiers: 0S-15-7NCI-2016-00352P30CA014089
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Gastrointestinal Stromal Tumor; Premenopausal

Outcome Measures

Primary Outcomes (1)

• Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer

  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.

  Baseline to up to 1 year

Secondary Outcomes (1)

• Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation

  Up to 1 year

Study Arms (1)

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; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Ultrasonography

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo collection of serum

Also known as: Cytologic Sampling

Ancillary-Correlative (ovary imaging, hormonal analysis)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (ovary imaging, hormonal analysis)

Questionnaire Administration OTHER

Ancillary studies

Ancillary-Correlative (ovary imaging, hormonal analysis)

Ultrasonography PROCEDURE

Undergo transvaginal pelvic ultrasonography

Also known as: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Ancillary-Correlative (ovary imaging, hormonal analysis)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Irene Woo

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (1)