Natural History Study of Children and Adults With Chordoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression
研究概览
简要总结
Background:
Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease.
Objective:
To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments.
Eligibility:
People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016
Design:
Participants will be screened with their medical history.
Participants will have a visit to examine their disease. This will include:
- Physical exam
- Neurologic exam
- CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body.
Participants will have other tests every 6-12 months:
- Smell test
- Surveys to assess their emotional, physical, and behavioral well-being and needs
- Cognitive function tests
Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations.
Some participants may be asked to come to the clinic for more visits.
详细描述
Background:
- Chordomas are a rare tumor with an incidence of 325 new cases per year in the United States. Pediatric chordomas are very rare and comprise only 5% of all chordoma cases.
- The standard therapy for localized primary or recurrent chordomas is surgical resection. However, complete surgical resection is often not possible due to the location of the
chordoma.
-For chordomas that cannot be surgically resected, treatment options are limited. Currently,
no standard therapy approach exists for recurrent chordomas. In addition, there are no FDA approved medical therapies for chordoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document.
- •Subjects with radiographically or histologically documented chordoma
- •Age greater than or equal to 2 years old
- •Subjects must be enrolled into NCI protocol 19-C-0016: Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors .
排除标准
- 未提供
研究组 & 干预措施
1/Cohort 1
Subjects with confirmed chordoma.
结局指标
主要结局
To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression
时间窗: 10 years
Natural history of chordoma, including clinical presentation and patterns of disease progression
次要结局
未报告次要终点