Hematological MalignanciesHemaTMANCT04142372
Tissue Microarray of Hematological Malignancies
An observational study of Hematological Malignancies, run by Tampere University Hospital at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Malignancies
- How many people
- 5,000 participants
- Where
- 1 siteFinland
- Study dates
- 10 Mar 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with new hematological malignancies 1.1.2000- 30.4.2019
Who may be able to join
- hematological malignancy/neoplasm
Who cannot join
- Non-sufficient data available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Anemia, Refractory, with Excess of Blasts, Myeloproliferative Disorders, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: From the first line treatment up to the end of the study period (April 2019).
Secondary outcomes (12)
Sepsis or other life-threatening infection
Fulminant infection after diagnosis
Measured: 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
Measured: From the first line treatment up to the end of the study period (April 2019).
Thrombo-embolism
Venous thromboembolism
Measured: From the first line treatment up to the end of the study period (April 2019).
Disease transformation
Hematological malignancy transforms into another malignancy
Measured: From the diagnosis up to the end of the study period (April 2019).
ICU admission
Admission to intensive care unit
Measured: From the first line treatment up to the end of the study period (April 2019).
Adverse effects
Treatment-related adverse effects/events
Measured: 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
Measured: From the first line treatment up to the end of the study period (April 2019).
Relapse
Relapse after or during the treatment.
Measured: From the first line treatment up to the end of the study period (April 2019).
Complete remission
Complete remission after the treatment
Measured: From the first line treatment up to the end of the study period (April 2019).
Time to complete remission
Time to complete remission
Measured: 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
Measured: 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
Measured: From the first line treatment up to the end of the study period (April 2019).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start10 Mar 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Eastern Finland, Fimlab Oy, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Matti Vänskä, Tampere University
- Investigators
- Artturi Mäkinen, MD, Principal investigator, Tampere UniversityOlli Lohi, MD, PhD, Study chair, Tampere UniversityMerja Heinäniemi, PhD, Study chair, University of Eastern FinlandMatti Vänskä, MD, PhD, Principal investigator, Tampere University HospitalTiina Lyly-Yrjänäinen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142372
- Sponsor's protocol ID
- R19060B
- Acronym
- HemaTMA
- Status last verified
- Apr 2024
- First submitted
- 18 Sep 2019
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Microarray of Hematological Malignancies: Search for Novel Regulators of Disease Pathology Across Disease Entities
- ClinicalTrials.gov ID
- NCT04142372
- Acronym / sponsor ID
- HemaTMA / R19060B
- Conditions
- Hematological Malignancies
- Keywords
- leukemia, lymphoma, biomarker, prognosis, myeloma, myelodysplasia, myeloproliferative disorder, diagnostics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Eastern Finland, Fimlab Oy, Helsinki University Central Hospital
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with new hematological malignancies 1.1.2000- 30.4.2019
Key inclusion criteria (1 listed)
- hematological malignancy/neoplasm
Key exclusion criteria (1 listed)
- Non-sufficient data available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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.
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).
12 secondary outcomes
Sepsis or other life-threatening infection
Time frame: From the first line treatment up to the end of the study period (April 2019).
Multiple organ failure
Time frame: From the first line treatment up to the end of the study period (April 2019).
Thrombo-embolism
Time frame: From the first line treatment up to the end of the study period (April 2019).
Disease transformation
Time frame: From the diagnosis up to the end of the study period (April 2019).
ICU admission
Time frame: From the first line treatment up to the end of the study period (April 2019).
Adverse effects
Time frame: From the first line treatment up to the end of the study period (April 2019).
Secondary malignancy
Time frame: From the first line treatment up to the end of the study period (April 2019).
Relapse
Time frame: From the first line treatment up to the end of the study period (April 2019).
Complete remission
Time frame: From the first line treatment up to the end of the study period (April 2019).
Time to complete remission
Time frame: From the first line treatment up to the end of the study period (April 2019).
Best response
Time frame: From the first line treatment up to the end of the study period (April 2019).
Time to best response
Time frame: From the first line treatment up to the end of the study period (April 2019).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hematological Malignancies
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Characterization of CD180 Protein Expression in Myeloid Hematological Malignancies by Flow Cytometry
Acute Myeloid Leukemia, Myeloid Hematological Malignancies
RecruitingPhase 1
A Study of APG-3288 in Relapsed/Refractory Blood Cancers
Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
Not yet recruitingPhase 1/2
KATALYST-HEME-01: Study of the KAT6 Inhibitor MEN2312 in Heme Malignancies
Hematological Malignancy
RecruitingObservational study
Longitudinal Studies of Patient With FPDMM
Inherited Hematological Diseases, Rare Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artturi Mäkinen, MD principal investigator
Tampere University
Olli Lohi, MD, PhD study chair
Tampere University
Merja Heinäniemi, PhD study chair
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From the first line treatment up to the end of the study period (April 2019).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.