Tissue Microarray of Hematological Malignancies

Hematological Malignancies Clinical Trial

— HemaTMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04142372
• Other study ID #: R19060B
• Status: Active, not recruiting
• Start date: March 10, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• hematological malignancy/neoplasm

Exclusion Criteria:

• Non-sufficient data available

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Locations

Country	Name	City	State
Finland	Tampere Univerisity Hospital	Tampere

Sponsors (5)

Lead Sponsor	Collaborator
Tampere University Hospital	Fimlab Oy, Helsinki University Central Hospital, Tampere University, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	Thrombo-embolism	Venous thromboembolism	From the first line treatment up to the end of the study period (April 2019).
Secondary	Disease transformation	Hematological malignancy transforms into another malignancy	From the diagnosis up to the end of the study period (April 2019).
Secondary	ICU admission	Admission to intensive care unit	From the first line treatment up to the end of the study period (April 2019).
Secondary	Adverse effects	Treatment-related adverse effects/events	From the first line treatment up to the end of the study period (April 2019).
Secondary	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).
Secondary	Relapse	Relapse after or during the treatment.	From the first line treatment up to the end of the study period (April 2019).
Secondary	Complete remission	Complete remission after the treatment	From the first line treatment up to the end of the study period (April 2019).
Secondary	Time to complete remission	Time to complete remission	From the first line treatment up to the end of the study period (April 2019).
Secondary	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).
Secondary	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).