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NCT00006515 · ClinicalTrials.gov registry record
Late Effects of Treatment for Sarcomas in Children
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 39
- Enrollment target
NCT00006515: Completed study, sponsored by National Cancer Institute (NCI).
NCT00006515 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006515 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
Study Summary
This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers) in children. Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted. Patients previously treated for sarcoma in the NCI's Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy) for at least 24 months may be eligible for this 3- to 4-day study. It will review the incidence and extent of the following late effects of therapy. * Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to look for changes and compare the findings with information obtained by standard echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the heart). * Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production, leading to infertility, early menopause or brittle bones. Low sex hormone levels may also increase the risk for heart attack, obesity or fracture. Patients will have blood tests to measure hormone levels as well as mineral levels, lipid levels and blood cell counts. They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen. Males will be offered a semen analysis as part of the fertility evaluation. * Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships, jobs, insurance, education, health care, and personal and professional goal setting. Some patients may become depressed or develop a psychiatric illness. Patients will fill out a questionnaire about their treatment, recovery, and aspects of their curren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2000-11-16 |
| Est. Completion | 2011-11-18 |
What the finished NCT00006515 record still lists
NCT00006515 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 39 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00006515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006515 about?
NCT00006515 is a clinical study titled "Late Effects of Treatment for Sarcomas in Children". This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers) in children. Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted. Patients previously treated for sarcoma in the NCI's Pedia...
What is the current status of trial NCT00006515?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2000-11-16. Estimated completion is 2011-11-18.
Who is sponsoring clinical trial NCT00006515?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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