Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
|First Received Date ICMJE||November 21, 2006|
|Last Updated Date||March 16, 2012|
|Start Date ICMJE||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels [ Time Frame: Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points. ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00402935 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer|
|Official Title ICMJE||Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function|
RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment.
PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.
OUTLINE: This is a pilot, prospective study.
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
|Sampling Method||Non-Probability Sample|
|Study Population||premenopausal women undergoing chemotherapy for cancer|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||May 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||14 Years to 35 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00402935|
|Other Study ID Numbers ICMJE||CWRU3803
P30CA043703 ( US NIH Grant/Contract Award Number )
CASE-CWRU-3803 ( Other Identifier: Case Comprehensive Cancer Center )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Study Sponsor ICMJE||Case Comprehensive Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||Case Comprehensive Cancer Center|
|Verification Date||March 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP