Identification of a New Blood Biomarker for the Diagnosis and Prognosis of Liposarcomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Sensibility and specificity of circulating serine level for LPS diagnosis
研究概览
简要总结
The main objective of this project is to identify a new non-invasive biological test for the diagnosis of LPS by measuring circulating serine levels. The current gold standard is the detection of Mdm2 amplification by the FISH.
详细描述
Sarcomas are rare diseases, accounting for less than 1% of all malignant diseases in adults¹. Their incidence is about 6 new cases per 100,000 in inhabitants per year, ie 4,000 to 5,000 new cases estimated per year in France.
Liposarcoma (LPS) is the most common soft tissue sarcoma subtype, accounting for approximately 15% of all sarcomas.
The OMS classification distinguishes 5 categories of LPS: myxoid, pleomorphe, round-cell liposarcomas, dedifferentiated (DD-LPS) and well-differentiated (WD-LPS). Research team is interested by the last two in this study.
The diagnosis is suspected on the imaging examinations (MRI for limb tumors and CT for retro-peritoneal LPS) which should lead to a discussion at a multidisciplinary tumor board in an expert center to validate the biopsy for definitive diagnosis and define the best biopsy route to avoid the risk of spread. In France, the management of patients with sarcoma is organized around the network of 24 "NETSARC" centers.
WD-LPS and DD-LPS, may be difficult to distinguish from benign adipose tumors and undifferentiated sarcomas, respectively. Molecular analyze, based on the detection of Mdm2 gene amplification by Fluorescence in situ Hybridization (FISH) is currently the "gold standard". It is performed on a tumor biopsy. The biopsy is a radiologic biopsy as it is recommended in the guidelines to reduce the risk of disease spread. The material allowing the diagnosis is thus limited complicating the realization of morphology, immunohistochemistry and molecular biology on the same sample. The other limitation is that this tumor fragment does not always reflect intra-tumor heterogeneity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for LPS patients cohort:
- •Men/women older than 18 years old,
- •Surgery for :
- •Localized WD-LPS and DD-LPS, and/or
- •WD-LPS or DD-LPS local relapse, and/or
- •WD-LPS or DD-LPS distant relapse and/or
- •Deep adipocytic tumor greater than 5 cms, suggestive of atypical lipomatous tumor Patient accepting blood sample, Patient who signed informed consent
- •Inclusion Criteria for healthy subjects cohort:
- •Men/women older than 18 years old, Accepting blood sample, Who signed informed consent Matching on sex and age on LPS patient cohort
排除标准
- •Presence of NeoAdjuvant Treatment for the present cancer, Unaffiliated patient to French Social Protection System, Patient whose follow up is impossible for psychologic, social, geographic, familial reasons Psychiatric illness that would prevent the patient from giving informed consent or being compliant with the study procedures Patient who have another cancer within the 5 years of the inclusion except in situ breast carcinoma, in situ, basocellular carcinoma.
- •Pregnancy and/or feeding
结局指标
主要结局
Sensibility and specificity of circulating serine level for LPS diagnosis
时间窗: At 3 months post surgery
Circulating serine level is a quantitative variable evaluated by its concentration
次要结局
- Difference in circulating serine level(18 months after surgery)
- Relapse-free survival (RFS)(Until the study completion: 2 years)