Tissue Microarray of Hematological Malignancies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tissue Microarray of Hematological Malignancies: Search for Novel Regulators of Disease Pathology Across Disease Entities

Conditions
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Hematological Malignancies

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hematological malignancy/neoplasm Exclusion Criteria: Non-sufficient data available
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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). | From the first line treatment up to the end of the study period (April 2019). | 
| Overall survival (OS) | 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). | From the diagnosis up to the end of the study period (April 2019). | 
| Response to treatment | 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. | From the first line treatment up to the end of the study period (April 2019). | 
| Event-free survival (EFS) | 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). | From the first line treatment up to the end of the study period (April 2019). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis or other life-threatening infection | Fulminant infection after diagnosis | From the first line treatment up to the end of the study period (April 2019). | 
| Multiple organ failure | Altered organ function in acutely ill patient | From the first line treatment up to the end of the study period (April 2019). | 
| Thrombo-embolism | Venous thromboembolism | From the first line treatment up to the end of the study period (April 2019). | 
| Disease transformation | Hematological malignancy transforms into another malignancy | From the diagnosis up to the end of the study period (April 2019). | 
| ICU admission | Admission to intensive care unit | From the first line treatment up to the end of the study period (April 2019). | 
| Adverse effects | Treatment-related adverse effects/events | From the first line treatment up to the end of the study period (April 2019). | 
| Secondary malignancy | Secondary malignancy after the diagnosis of hematological malignancy | From the first line treatment up to the end of the study period (April 2019). | 
| Relapse | Relapse after or during the treatment. | From the first line treatment up to the end of the study period (April 2019). | 
| Complete remission | Complete remission after the treatment | From the first line treatment up to the end of the study period (April 2019). | 
| Time to complete remission | Time to complete remission | From the first line treatment up to the end of the study period (April 2019). | 
| Best response | Best response e.g. hematological remission, molecular remission, radiological remission | From the first line treatment up to the end of the study period (April 2019). | 
| Time to best response | Time to best response e.g. hematological remission, molecular remission, radiological remission | From the first line treatment up to the end of the study period (April 2019). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukemia, lymphoma, biomarker, prognosis, myeloma, myelodysplasia, myeloproliferative disorder, diagnostics, tissue microarray, proteomics, genomics, clinical outcome, biobanking, digitalization, data mining, hematology, oncology, pathology, bioinformatics, real world data, hematological malignancy, survival, treatment response