Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Obtention of a genic-proteomic profile of TB lesions tissues which correlate to the histopathology of the granulomas and/or the clinic-pathological features of TB patients
研究概览
简要总结
The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential information
- on the role of the host in the mechanisms associated to the generation and evolution of active TB and
- about future diagnostic and/or prognostic biomarkers of TB disease. All this information could be used for patients stratification and/or to design new therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine
排除标准
- •Non consenting to donate samples and/or data for the study
结局指标
主要结局
Obtention of a genic-proteomic profile of TB lesions tissues which correlate to the histopathology of the granulomas and/or the clinic-pathological features of TB patients
时间窗: at baseline
only for Prospective Substudy; descriptive analysis, correlation with histopathological characteristics of TB lesions and with clinical and epidemiological data of TB patients
Description of the Histopathological characteristics of the TB lesions of TB patients enrolled
时间窗: at baseline
for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc
Description of Clinical and Epidemiological Data of the TB patients enrolled
时间窗: at baseline
for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc
次要结局
- Change in Immunological responses(at baseline; and at the moment of discharge, an average of at day 15 post-enrollment)
- Change in Health Quality of Life Measurements(at baseline (before surgery) and through study completion, an average of 1 year)
研究者
Cris Vilaplana
Senior Researcher at the Experimental Tuberculosis Unit
Fundació Institut Germans Trias i Pujol