Tissue Microarray of Hematological Malignancies (HemaTMA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematological Malignancies

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, FI-33270
    • Tampere Univerisity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with new hematological malignancies 1.1.2000- 30.4.2019

Description

Inclusion Criteria:

• hematological malignancy/neoplasm

Exclusion Criteria:

• Non-sufficient data available

Study Plan

How is the study designed?

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Helsinki University Central Hospital; Tampere University; University of Eastern Finland; Fimlab Oy
• Investigators: Principal Investigator: Artturi Mäkinen, MD, Tampere University; Study Chair: Olli Lohi, MD, PhD, Tampere University; Study Chair: Merja Heinäniemi, PhD, University of Eastern Finland; Principal Investigator: Matti Vänskä, MD, PhD, Tampere University Hospital; Principal Investigator: Tiina Lyly-Yrjänäinen, MD, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: lymphoma; oncology; biomarker; prognosis; survival; genomics; myelodysplasia; bioinformatics; leukemia; hematology; real world data; diagnostics; proteomics; clinical outcome; treatment response; data mining; hematological malignancy; myeloma; pathology; myeloproliferative disorder; biobanking; digitalization; tissue microarray
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: R19060B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No