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Active, Not Recruiting

NCT Number: NCT04142372

Tissue Microarray of Hematological Malignancies

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hematological Malignancies Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere Univerisity Hospital

Tampere, FI-33270, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hematological malignancy/neoplasm

Exclusion criteria

  • Non-sufficient data available

Treatment and study plan

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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).

  2. Overall survival (OS)

    Time frame: 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).

  3. Response to treatment

    Time frame: 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.

  4. Event-free survival (EFS)

    Time frame: 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 outcomes

  1. Sepsis or other life-threatening infection

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Fulminant infection after diagnosis

  2. Multiple organ failure

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Altered organ function in acutely ill patient

  3. Thrombo-embolism

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Venous thromboembolism

  4. Disease transformation

    Time frame: From the diagnosis up to the end of the study period (April 2019).

    Hematological malignancy transforms into another malignancy

  5. ICU admission

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Admission to intensive care unit

  6. Adverse effects

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Treatment-related adverse effects/events

  7. Secondary malignancy

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Secondary malignancy after the diagnosis of hematological malignancy

  8. Relapse

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Relapse after or during the treatment.

  9. Complete remission

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Complete remission after the treatment

  10. Time to complete remission

    Time frame: From the first line treatment up to the end of the study period (April 2019).

    Time to complete remission

  11. Best response

    Time frame: 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

  12. Time to best response

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Fimlab Oy
  • Helsinki University Central Hospital
  • Tampere University
  • University of Eastern Finland

Registry information

Official study title

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

Acronym: HemaTMA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2019
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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