Blood CancerHemascopioNCT06574308
Clinical Evaluation of the Scopio Cell Morphology Technology
An observational study of Blood Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Cancer
- What is being tested?
- Blood cells classification
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pazienti affetti da emopatie
Who may be able to join
- Patients suffering from hemopathies with bone marrow aspirate assessable under the optical microscope
Who cannot join
- Patients not affected by blood disorders
- Patients suffering from hemopathies with bone marrow aspirate that cannot be assessed under the optical microscope
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Scopio Cell Morphology Technology on Pre-classification of Blood Cells in Peripheral Blood (PB) and Bone Marrow (BM)
Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)
- Conditions
- Blood Cancer
- Being tested
- Blood cells classification
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood cells classificationDiagnostic test
Comparison of the classification of peripheral blood and bone marrow cells with optical microscope reading with pre-classification using Scopio technology (AI based)
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical microscope reading and automatic pre-classification
Comparison between optical microscope reading and automatic pre-classification (AI based)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizia Chiusolo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574308
- Sponsor's protocol ID
- 6901
- Acronym
- Hemascopio
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Scopio Cell Morphology Technology on Pre-classification of Blood Cells in Peripheral Blood (PB) and Bone Marrow (BM)
- ClinicalTrials.gov ID
- NCT06574308
- Acronym / sponsor ID
- Hemascopio / 6901
- Conditions
- Blood Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pazienti affetti da emopatie
Key inclusion criteria (1 listed)
- Patients suffering from hemopathies with bone marrow aspirate assessable under the optical microscope
Key exclusion criteria (2 listed)
- Patients not affected by blood disorders
- Patients suffering from hemopathies with bone marrow aspirate that cannot be assessed under the optical microscope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood cells classificationComparison of the classification of peripheral blood and bone marrow cells with optical microscope reading with pre-classification using Scopio technology (AI based) | Diagnostic test | – |
Primary outcome
Optical microscope reading and automatic pre-classification
Time frame: 12 months
Comparison between optical microscope reading and automatic pre-classification (AI based)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Patrizia Chiusolo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Blood Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Aug 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Chiusolo, MD (+390630154206, patrizia.chiusolo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical microscope reading and automatic pre-classification (time frame: 12 months). 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 27 Aug 2024.