|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00402935 |
|
Date of registration:
|
21/11/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
|
|
Scientific title:
|
Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function |
|
Date of first enrolment:
|
February 2004 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00402935 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Marjorie Greenfield, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| | |
|
Key inclusion & exclusion criteria
|
DISEASE CHARACTERISTICS:
- Diagnosis of cancer, including, but not limited to, any of the following:
- Acute lymphocytic leukemia
- Acute myeloid leukemia
- Hodgkin's lymphoma
- Must have primary disease with significant chance for long-term survival after
therapy
- Scheduled to receive chemotherapeutic agents known to be associated with ovarian
failure, including any of the following:
- Cyclophosphamide
- Mechlorethamine hydrochloride
- Busulfan
- Procarbazine hydrochloride
- Chlorambucil
- Melphalan
- Ifosfamide
- Cisplatin
- Carboplatin
- Postmenarchal and premenopausal
PATIENT CHARACTERISTICS:
- Female
- Weight = 250 pounds
- Not pregnant
PRIOR CONCURRENT THERAPY:
- No prior or concurrent total-body irradiation or radiotherapy to the pelvis
- Concurrent bone marrow transplantation allowed
- Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed
Age minimum:
14 Years
Age maximum:
35 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Leukemia
|
|
Long-term Effects Secondary to Cancer Therapy in Adults
|
|
Long-term Effects Secondary to Cancer Therapy in Children
|
|
Lymphoma
|
|
Sexual Dysfunction and Infertility
|
|
Sexuality and Reproductive Issues
|
|
Unspecified Adult Solid Tumor, Protocol Specific
|
|
Unspecified Childhood Solid Tumor, Protocol Specific
|
|
Intervention(s)
|
|
Other: laboratory biomarker analysis
|
|
Procedure: fertility assessment and management
|
|
Procedure: management of therapy complications
|
|
Procedure: ultrasound imaging
|
|
Primary Outcome(s)
|
|
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.]
|
|
Secondary ID(s)
|
|
CASE-01-04-15
|
|
CASE-CWRU-3803
|
|
CWRU3803
|
|
P30CA043703
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|