Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
|ClinicalTrials.gov Identifier: NCT00402935|
Recruitment Status : Withdrawn (slow accrual)
First Posted : November 23, 2006
Last Update Posted : March 20, 2012
|First Submitted Date||November 21, 2006|
|First Posted Date||November 23, 2006|
|Last Update Posted Date||March 20, 2012|
|Study Start Date||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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||Not Provided|
|Change History||Complete list of historical versions of study NCT00402935 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer|
|Official Title||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 Design||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.
|Actual Study Completion Date||May 2007|
|Primary Completion Date||Not Provided|
PRIOR CONCURRENT THERAPY:
|Ages||14 Years to 35 Years (Child, 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|
|Other Study ID Numbers||CWRU3803
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CWRU-3803 ( Other Identifier: Case Comprehensive Cancer Center )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Study Sponsor||Case Comprehensive Cancer Center|
|Collaborators||National Cancer Institute (NCI)|
|PRS Account||Case Comprehensive Cancer Center|
|Verification Date||March 2012|