Tissue Microarray of Hematological Malignancies: Search for Novel Regulators of Disease Pathology Across Disease Entities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
The aim of the study is to create new tools for improving management of patients with hematological malignancies by combining extensive clinical data from patients newly diagnosed with hematological malignancies and innovative laboratory analyses made on available tissue samples in regional biobanks from these patients.
详细描述
Firstly, clinical information is collected on all hematological malignancies diagnosed in our hospital district area retrospectively between the years 2000 and 2019. Clinical outcomes, laboratory results, clinically relevant diagnoses, characteristics defining clinical stage and established prognostic parameters are gathered.
Simultaneously a tissue microarray (TMA) of diagnostic samples is compiled using representative annotated tissue areas. This TMA is used in combination with additional control material to identify prognostic and predictive biomarkers.
A combined microarray dataset of hematological malignancies (Hemap) is utilized to point out genes of possible drug targets, disease specific markers, prognostic markers, or predictive markers.
The clinical datasets and Hemap dataset is ultimately utilized to gain knowledge, new tools for prognostication and diagnostics, and targets for treatment. Artificial intelligence -assisted differential diagnostics will be tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hematological malignancy/neoplasm
排除标准
- •Non-sufficient data available
结局指标
主要结局
Response to treatment
时间窗: From the first line treatment up to the end of the study period (April 2019).
Best response to the first line treatment for the hematological malignancy, according to malignancy in question, e.g. complete response (CR), stringent complete response (sCR), partial response (PR), very good partial response (VGPR), stable disease (SD), progressive disease (PD), treatment failure, clinical response, hematological response etc.
Event-free survival (EFS)
时间窗: From the first line treatment up to the end of the study period (April 2019).
Survival time from the first line treatment for hematological malignancy until any primary event (death, relapse, disease progression/transformation, secondary malignancy, resistant disease etc.), whichever came first, assessed up to the end of the study period (April 2019).
Progression-free survival (PFS)
时间窗: From the first line treatment up to the end of the study period (April 2019).
Time from the first line treatment for hematological malignancy until the date of first documented relapse or transformation or death of any cause, whichever came first, assessed up to the end of the study period (April 2019).
Overall survival (OS)
时间窗: From the diagnosis up to the end of the study period (April 2019).
Survival time from the diagnosis of hematological malignancy until the date of death of any cause, assessed up to the end of the study period (April 2019).
次要结局
- Thrombo-embolism(From the first line treatment up to the end of the study period (April 2019).)
- Best response(From the first line treatment up to the end of the study period (April 2019).)
- Disease transformation(From the diagnosis up to the end of the study period (April 2019).)
- Adverse effects(From the first line treatment up to the end of the study period (April 2019).)
- Sepsis or other life-threatening infection(From the first line treatment up to the end of the study period (April 2019).)
- Time to complete remission(From the first line treatment up to the end of the study period (April 2019).)
- Time to best response(From the first line treatment up to the end of the study period (April 2019).)
- Multiple organ failure(From the first line treatment up to the end of the study period (April 2019).)
- ICU admission(From the first line treatment up to the end of the study period (April 2019).)
- Relapse(From the first line treatment up to the end of the study period (April 2019).)
- Secondary malignancy(From the first line treatment up to the end of the study period (April 2019).)
- Complete remission(From the first line treatment up to the end of the study period (April 2019).)
研究者
Matti Vänskä
Principal Investigator, MD PhD
Tampere University