T1622 The Registry Study of Genetic Alterations of Melanoma in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- To evaluate the evolution of acral melanoma patients in Taiwan.
研究概览
简要总结
Cutaneous melanoma is the most aggressive malignancy in skin cancers. Cutaneous melanoma is a rare disease in Taiwan with an incidence rate of around 1/100,000. Acral lentiginous melanoma is the most common subtype and comprises more than half of cutaneous melanoma in Asia including Taiwan but only 1% in Caucasians. In addition, mucosal melanoma accounts for more than 20% of malignancy melanoma in Taiwan but only 1% in Caucasians. Acral and mucosal melanomas have distinct epidemiological, clinical, pathological and genetic features from non-acral melanoma which is commonly seen in Western countries. Comparing with melanoma in Caucasians, Asian melanoma has higher recurrence rate after primary surgery, lower response rate to immunotherapy, and shorter progression-free survival for immunotherapy and targeted therapy leading generally poor survival outcomes regardless stage.
详细描述
Most melanoma patients present with locally advanced or metastatic disease at diagnosis reflecting the aggressive disease nature of melanoma in Taiwan. Currently, surgical resection of primary tumor and lymph node dissection are the main treatment for patients with locally advanced melanoma. Adjuvant therapy should be considered for stage III melanoma. Unfortunately, most patients recur after above aggressive treatment. Systemic treatment including targeted therapy, immunotherapy and chemotherapy is the main for unresectable or metastatic melanoma. The prognosis of these patients remains poor with a median survival time around a year. Therefore, a better understanding of this deadly disease is crucial and finding better therapeutic strategies for these patients and stratifying patients with suitable treatment are urgent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age > 18 years old
- •Pathologically confirmed melanoma. (Patients with additional malignancies requiring treatment or follow-up are allowed. Only treatment for melanoma should be recorded).
- •ECOG performance status < 3
- •Cohort 1(early acral melanoma): melanoma, stage I/II; Cohort 2 (locally advanced acral melanoma): melanoma, stage III, resectable; and Cohort 3 (advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition). The patients with advanced melanoma with available comprehensive NGS report are included in cohort
- •Willingness to provide archival or newly obtained tumor tissues for this study proposal
- •Life expectancy more than 3 months -
- •Patients fully understand the protocol with the willingness to have regular follow-up
排除标准
- •Inability to cooperate by providing a complete medical history
- •No available tumor tissues for genetic testing (archived tissue sampling more than 5 years from screening date)
- •Undesirable compliance (Mental status is not fit for further treatment or data collection.)
结局指标
主要结局
To evaluate the evolution of acral melanoma patients in Taiwan.
时间窗: Duration of Enrollment: 2022/10-2025/12
1. Collecting the tissues from melanoma patients for NGS studies, One H\&E staining slide, and 10 tissue slides (4-5 um thickness) for cancer panel-based next generation sequencing analysis, including fusion panel (10 slides) will be required (first priority). 2. Non-tumor Sample (Blood): Fifteen (15) ml of blood will be collected from the participant: 7 ml in EDTA tube (purple top) and 8 ml in Cell-Free DNA blood collection tube. These blood samples will be separated into peripheral blood mononuclear cells and plasma specimens for germline mutation analysis and potential biomarker study, respectively. 3. Non-tumor Sample (Stool for microbiota):Collecting stool specimens before systemic treatment (for prospective cohort), 2-3 months after initiating targeted therapy or immunotherapy. IHC staining for specific biomarkers such as MDM2 and HER2 will be evaluated.
次要结局
未报告次要终点