Prognostic impact of mutational analysis and it’s therapeutic implications in Gastrointestinal Stromal Tumours (GIST)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To assess the mutation pattern at baseline and follow-up patients with newly diagnosed GISTs
研究概览
简要总结
1 M/c mesenchymal malignancy; 1-2% GI malignancies
2 Arises from the pluripotent mesenchymal cells
3 M/c site: Stomach & small intestine
4 ~47% present in advanced stage. Liver or peritoneal metastatic involvement
5 CT is gold standard for abdominal primaries with use of oral + i/v contrast improves evaluation of tumour margin
6 best categorized by molecular subtype, which have differing clinical characteristics and treatment response KIT (~69%–83%) PDGFRA (~5%–10%),10%– 15% of GISTs without KIT/PDGFRA mutations. SDC deficiency or BRAF or loss-of-function of NF1, that lead to activation of the PI3K/ mTOR and/or the RAS/RAF/MAPK pathways
7 In the era of precision oncology, tailored treatment protocols based on medical genetics form the basis of evidence-based management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Newly diagnosed case of GIST 2 Treatment naïve Diagnosis will be based upon the morphology and immunophenotype of the primary followed by mutational analysis.
排除标准
- •1 Consent refusal 2 Patients with inadequate sample in tissue biopsy.
结局指标
主要结局
To assess the mutation pattern at baseline and follow-up patients with newly diagnosed GISTs
时间窗: 3 months 6 months 9 months 12 months
次要结局
- To audit retrospective data for mutational analysis profile clinicopathological findings & OS over a period of 5 years (2017-2022).(PFS & OS will be prospectively observed in patient cohort)
研究者
Dr Antara Sanyal
Institute of Medical sciences and SUM Hospital