Chronic Myelogenous Leukemia, BCR-ABL1 PositiveNCT02734823
Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor
An observational study of Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Gastrointestinal Stromal Tumor, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor, Premenopausal
- What is being tested?
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor, Premenopausal
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Questionnaire Administration, Ultrasonography
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of serum
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
UltrasonographyProcedure or surgery
Also called ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical
Undergo transvaginal pelvic ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The results of their stimulation protocol will be recorded.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Mar 2016
- Primary completion14 Mar 2024 (estimated)
- Study completion14 Mar 2024 (estimated)
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia, BCR-ABL1 PositiveStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Irene Woo, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734823
- Sponsor's protocol ID
- 0S-15-7
- Other IDs
- NCI-2016-00352, 0S-15-7, P30CA014089
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2016
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
- ClinicalTrials.gov ID
- NCT02734823
- Acronym / sponsor ID
- 0S-15-7
- Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor, Premenopausal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 14 Mar 2024 (estimated)
- Study completion
- 14 Mar 2024 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (ovary imaging, hormonal analysis) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Procedure: UltrasonographyPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of serum | Other | Ancillary-Correlative (ovary imaging, hormonal analysis) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (ovary imaging, hormonal analysis) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-Correlative (ovary imaging, hormonal analysis) |
| UltrasonographyAlso: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, MedicalUndergo transvaginal pelvic ultrasonography | Procedure or surgery | Ancillary-Correlative (ovary imaging, hormonal analysis) |
Primary outcome
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.
1 secondary outcome
Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Woo principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Gastrointestinal Stromal Tumor, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer (time frame: Baseline to up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.