Tissue Microarray of Hematological Malignancies

NCT04142372 | Active Not Recruiting

• 1 other identifier: R19060B
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancies

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Sepsis or other life-threatening infection

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

• Multiple organ failure

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

• Thrombo-embolism

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

• Disease transformation

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

• ICU admission

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with new hematological malignancies 1.1.2000- 30.4.2019

You may qualify if:

• hematological malignancy/neoplasm

You may not qualify if:

• Non-sufficient data available

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• University of Eastern Finland: collaborator
• Fimlab Oy: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Tampere Univerisity Hospital

Tampere, FI-33270, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Diagnostic samples containing cells and tissues.

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Neoplasms, Plasma Cell; Anemia, Refractory, with Excess of Blasts; Myeloproliferative Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Officials

• Artturi Mäkinen, MD

  Tampere University

  PRINCIPAL INVESTIGATOR

• Olli Lohi, MD, PhD

  Tampere University

  STUDY CHAIR

• Merja Heinäniemi, PhD

  University of Eastern Finland

  STUDY CHAIR

• Matti Vänskä, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Tiina Lyly-Yrjänäinen, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD PhD

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 29, 2019
• Study Start: March 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FI (1)