Retrospective analysis of clinical outcome and clinical next-generation sequencing application in malignant peritoneal mesothelioma patients treated in a tertiary cancer care center in India
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To study the overall survival of the peritoneal mesothelioma.
概览
简要总结
Study design: Retrospective study
Study setting: Medical Oncology Parel, TMH, and ACTREC, Kharghar
Study duration: January 2014 to December 2023
Study population: Patients with peritoneal mesothelioma treated in Parel TMH in the determined time period
Study methodology: It is a hospital based retrospective study. All the patients who received treatment at Parel TMH from January 2014 to December 2023 will be analyzed. All data will be collected from the electronic medical record of the hospital. The details will be captured as mentioned in the case report form.
Objectives:
- Primary objective: To study the survival outcomes of malignant peritoneal mesothelioma patients
- Secondary objective: To analyze the baseline demographic characteristics of peritoneal mesothelioma patients and to assess the molecular characteristics of peritoneal mesothelioma patients by using NGS
Sample size: 60 to 70 patients who underwent treatment from January 2014 to December 2023 will be included in this study
Molecular analysis: NGS will be performed on formalin fixed paraffin embedded tissue
Ethics: Waiver of consent is requested as the study involves less than minimal risk and there is no direct contact between the researcher and the participant
Statistical analysis: Descriptive statistics for demographic and clinical variables will be performed. Kaplan Meier method will be used for survival analysis. The data will be analyzed in IBM SPSS v25
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 70 years at the time of diagnosis.
- •Histopathological confirmation of malignant peritoneal mesothelioma.
- •Receipt of treatment/ treatment plan (systemic chemotherapy, surgery, or both) from TMH, Parel.
排除标准
- •Patients who were diagnosed at TMH but received treatment elsewhere.
- •Incomplete clinical records.
- •Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks at TMH for genomic analysis is not compulsory.
结局指标
主要结局
To study the overall survival of the peritoneal mesothelioma.
时间窗: date of diagnosis till date of death: baseline till patient date of death
次要结局
- To study the progression-free survival of peritoneal mesothelioma patients.
- Baseline demographic characteristics of peritoneal mesothelioma patients.(basline)
- Molecular Characterization Analysis by NGS.(Baseline)
研究者
Prabhat Ghanshyam Bhargava
Tata Memorial Hospital