Hematological Malignancies
Conditions
Keywords
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
Brief summary
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
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.
Interventions
None listed
Sponsors
Tampere University
University of Eastern Finland
Fimlab Oy
Helsinki University Central Hospital
Tampere University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* hematological malignancy/neoplasm
Exclusion criteria
* Non-sufficient data available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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) | 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). |
| Response to treatment | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU admission | From the first line treatment up to the end of the study period (April 2019). | Admission to intensive care unit |
| Adverse effects | From the first line treatment up to the end of the study period (April 2019). | Treatment-related adverse effects/events |
| Secondary malignancy | From the first line treatment up to the end of the study period (April 2019). | Secondary malignancy after the diagnosis of hematological malignancy |
| Relapse | From the first line treatment up to the end of the study period (April 2019). | Relapse after or during the treatment. |
| Sepsis or other life-threatening infection | From the first line treatment up to the end of the study period (April 2019). | Fulminant infection after diagnosis |
| Time to complete remission | From the first line treatment up to the end of the study period (April 2019). | Time to complete remission |
| Best response | From the first line treatment up to the end of the study period (April 2019). | Best response e.g. hematological remission, molecular remission, radiological remission |
| Time to best response | From the first line treatment up to the end of the study period (April 2019). | Time to best response e.g. hematological remission, molecular remission, radiological remission |
| Complete remission | From the first line treatment up to the end of the study period (April 2019). | Complete remission after the treatment |
| Multiple organ failure | From the first line treatment up to the end of the study period (April 2019). | Altered organ function in acutely ill patient |
| Thrombo-embolism | From the first line treatment up to the end of the study period (April 2019). | Venous thromboembolism |
| Disease transformation | From the diagnosis up to the end of the study period (April 2019). | Hematological malignancy transforms into another malignancy |
Countries
Finland
Outcome results
None listed