ICONIC: Improving Outcomes Through Collaboration in OsteosarComa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Main Study: Patient recruitment
研究概览
简要总结
There has been little improvement in outcome for patients with osteosarcoma (OS) over the last 20 years. There have been only a few clinical trials of new treatments and no major new therapies introduced recently. This is in part because there is no good understanding of the biology of osteosarcoma, but also trials have only included subgroups of patients. The more that is understood about how and why osteosarcoma arises and grows the better clinicians will be able to decide what treatments are most likely to work best.
The purpose of this project is to collect high quality clinical data about patients of all ages with osteosarcoma, such as information about the size of the disease, how it was diagnosed and where it is at diagnosis, what treatments were given and how the disease responded the treatments.
Blood and tissue samples will also be collected for analysis in research laboratories. By looking at the results of the laboratory findings and the clinical data together, the questions will start to be answered about why osteosarcomas arise and grow, what makes it spread, and why some patients respond to treatment better than others. As time goes on, this information is planned to be used to develop clinical trials of new treatments.
Alongside this, the aim is to find out more about how osteosarcoma and its treatments affect the lives of those living with this disease. This information will help provide the most appropriate care and support that will meet the needs of each patient.
Ultimately, the aim is to improve the care and treatment of osteosarcoma patients so that they may live longer and better lives.
详细描述
Osteosarcoma is the most common bone sarcoma, accounting for approximately 30% of all bone sarcoma diagnoses. In England, it accounts for approximately 130 cases per year across all ages.
Generally osteosarcoma has an early peak in adolescent patients, with a second peak in patients over 60 years of age. There are differing treatments, including chemotherapy with more than one drug and surgery to the primary site - and for metastases where these occur.
Outcome, however, has improved little over the past 25 years with the proportion of patients surviving to 5 years remaining at about 42% for all ages and stages in the UK. Patients under 40 years of age (52%) are more likely to survive for 5 years than patients over 40 years (25%).
Survival also depends on the primary site of the osteosarcoma. It is poor for patients with tumours that are not in the limbs, at 36% for patients under the age of 40 years and as low as 6% for patients over 40 years. Also patients with metastatic disease at diagnosis still have a poor outcome.
The use of chemotherapy and surgery depends on factors such as age, the site of the osteosarcoma, how far spread it is and how well the patient is generally, with approximately two thirds of patients currently receiving chemotherapy, radiotherapy and surgery in England each year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New histological diagnosis of osteosarcoma or in the absence of osteoid seen on biopsy, pathology and imaging supportive of a diagnosis of osteosarcoma. (It is well recognised that some patients may present with features suggestive of osteosarcoma (under 40 years, radiological abnormality compatible) but in whom no osteoid is detected in needle biopsy. Although categorised as spindle cell tumour of bone, such patients are usually treated in an identical approach to osteosarcoma. A definite diagnosis of osteosarcoma is then often possible after surgery when the entire resection specimen is available.)
- •Written informed consent of patient and/or parent/legal guardian.
排除标准
- •Diagnosis more than four months prior to registration.
结局指标
主要结局
Main Study: Patient recruitment
时间窗: 3 years from study opening.
Enrolment of at least 300 patients with blood and specimen samples at specified time points.
Feasibility phase: Patient recruitment.
时间窗: One year from study opening.
To establish if a full study can be run, with a recruitment rate of ≥ 5 patients per month when 15 sites are open
次要结局
- Correlation of chemotherapy and radiotherapy to outcome(4 years from registration.)
- Analysis of circulating biomarkers(4 years from registration.)
- Analysis of PMBCs for IO research(4 years from registration.)
- Patient reported outcomes(4 years from registration.)
- Do tumour margin and response to chemotherapy predict local recurrence in OS?(4 years from registration.)
- Correlation of tumour heterogeneity and clonal evolution to chemotherapy response and patient outcome.(4 years from registration.)
- Validation of whole genome sequencing(4 years from registration.)