Acute Myelocytic LeukemiaNCT06764589
Liquid Micro-biopsy: a Novel Approach to Study Tumor Microenvironment From the Peripheral Blood
An observational study of Acute Myelocytic Leukemia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
This is a prospective multicentre, tissue-based, non-profit study that includes two enrolling centres: Operating Unit (OU) No. 1 of Haematology and OU No. 2 of Medical Oncology, both at the IRCCS Azienda Ospedaliera-Universitaria di Bologna (AOUBO). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myelocytic Leukemia
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Dec 2024to 2 Dec 2027
- How long will I take part?
- 36 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The planned population size for the study is 90 prospectively enrolled patients, 30 for each of the three study groups. No sample size calculations were performed due to the exploratory nature of this study.
Who may be able to join
- For HD:
- Age ≥ 18 years
- Volunteer in general good health, free from any disease or serious illness
- Signed written informed consent to study participation and personal data processing
- For AML patients:
- Age ≥ 18 years
Show all 13Show fewer
- New diagnosis of AML according to World Health Organization 2022 criteria
- Front-line treatment according to routine clinical practice
- Signed written informed consent to study participation and personal data processing
- For sarcoma patients:
- Age ≥ 18 years
- Diagnosis of visceral soft tissue sarcoma according to World Health Organization 2021 criteria in metastatic setting
- Signed written informed consent to study participation and personal data processing
Who cannot join
- For HD:
- None
- For AML and sarcoma patients:
- Acute promyelocytic leukemia (for AML)
- Known AML with central nervous system involvement (for AML)
- Visceral sarcoma in adjuvant setting (for sarcoma)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
IRCCS Azienda-Ospedaliero Universitaria di Bologna
Bologna, 40138
About this study
This is a prospective multicentre, tissue-based, non-profit study that includes two enrolling centres: Operating Unit (OU) No. 1 of Haematology and OU No. 2 of Medical Oncology, both at the IRCCS Azienda Ospedaliera-Universitaria di Bologna (AOUBO). Given the rarity of the pathology investigated and the lack of evidence from the literature, the study should be considered exploratory, aimed at providing provisional evidence and generating hypotheses that could be tested in future studies.
The study involves the collection of peripheral blood samples from healthy volunteers (HD) matched for sex/age (n=30; Group 1) and patients with acute myeloid leukaemia at diagnosis (n=30; Group 2) at UO1 and patients with visceral sarcoma with measurable disease (n=30; Group 3) at UO2.
Read more
Specifically, peripheral blood (equal to 60 mL) from healthy volunteers will be collected after obtaining the signed informed consent of the volunteers of the Associazione Onlus AIL Bologna ODV.
From all participants in Groups 2 and 3, 60 mL of peripheral blood and 20 mL of bone marrow blood will be collected at routine clinical examinations. Bone biopsies (10 sections) will also be collected from Group 2 patients. All samples will be collected at the time of diagnosis (T0). All samples will be centralised at the Haematology Unit, IRCCS AOUBO and submitted for laboratory analysis.
For patients with acute myeloid leukaemia, responses to treatment will be assessed on the basis of standard criteria according to the recommendations of the European LeukemiaNet of 2022 (Döhner H et al, Blood 2022). Clinical response for sarcoma patients according to the international RECIST imaging criteria assessed by routine computed tomography or magnetic resonance imaging scans.
Read the detailed description
Survival of AML is globally poor, with an overall survival at 5 years largely inferior to 50%. The diagnosis of several diseases, such as AML relies on invasive procedures. An increasing amount of evidence supports the straightforward relations between bone marrow (BM) biopsies and blood in hematological malignancies, including AML. Novel approaches to the characterization of TME have been developed. In this regard, scRNA-seq analysis emerged as a potent tool, capable of profoundly characterizing genomic profiles at the single-cell level. However, ST have the potential to improve our understanding of TME composition and cellular interactions, representing a powerful tool capable of identifying cell types and gene expression profiles on a structural and spatial level.
Since the question of a comprehensive characterization of tumor heterogeneity and cell-cell interactions is still unsolved, new ways to detect its modulation using blood are highly warranted for tumor diagnosing and monitoring. Indeed, conventional and invasive methods are insufficient to decipher the heterogeneous nature of tumors. Based on these premises, the driving hypothesis of the study is that performing an in-parallel analysis on both circulating cells and EVs might provide a broader characterization of the genomic landscape of tumors than using cells themselves. The integration of LB within the clinical management of cancer patients may represent an essential step towards a deeper understanding of cancer biology. It might have important implications for better disease monitoring and improved drug development.
- Conditions
- Acute Myelocytic Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Malignant signals (cell subsets and EV markers)
The percentages of positive/negative cells for each marker and the markers' geometric means are measured by flow cytometry and defined by negative control or by the value detected by HD (group 1) versus AML or sarcoma patients (group 2-3).
Measured: At diagnosis (T0)
Secondary outcomes (1)
2. Transcriptomic profile in cells and EVs
Gene count and transcript quantifications and computational analyses (deconvolution) are collected in HD (group 1) and AML or sarcoma patients (group 2-3).
Measured: At diagnosis (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start16 Dec 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelocytic LeukemiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Curti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764589
- Sponsor's protocol ID
- MICRO-biopsy
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Micro-biopsy: a Novel Approach to Study Tumor Microenvironment From the Peripheral Blood
- ClinicalTrials.gov ID
- NCT06764589
- Acronym / sponsor ID
- MICRO-biopsy
- Conditions
- Acute Myelocytic Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 8 Jan 2025 (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.
This is a prospective multicentre, tissue-based, non-profit study that includes two enrolling centres: Operating Unit (OU) No. 1 of Haematology and OU No. 2 of Medical Oncology, both at the IRCCS Azienda Ospedaliera-Universitaria di Bologna (AOUBO). Given the rarity of the pathology investigated and the lack of evidence from the literature, the study should be considered exploratory, aimed at providing provisional evidence and generating hypotheses that could be tested in future studies.
The study involves the collection of peripheral blood samples from healthy volunteers (HD) matched for sex/age (n=30; Group 1) and patients with acute myeloid leukaemia at diagnosis (n=30; Group 2) at UO1 and patients with visceral sarcoma with measurable disease (n=30; Group 3) at UO2.
Specifically, peripheral blood (equal to 60 mL) from healthy volunteers will be collected after obtaining the signed informed consent of the volunteers of the Associazione Onlus AIL Bologna ODV.
From all participants in Groups 2 and 3, 60 mL of peripheral blood and 20 mL of bone marrow blood will be collected at routine clinical examinations. Bone biopsies (10 sections) will also be collected from Group 2 patients. All samples will be collected at the time of diagnosis (T0). All samples will be centralised at the Haematology Unit, IRCCS AOUBO and submitted for laboratory analysis.
For patients with acute myeloid leukaemia, responses to treatment will be assessed on the basis of standard criteria according to the recommendations of the European LeukemiaNet of 2022 (Döhner H et al, Blood 2022). Clinical response for sarcoma patients according to the international RECIST imaging criteria assessed by routine computed tomography or magnetic resonance imaging scans.
Detailed description
Survival of AML is globally poor, with an overall survival at 5 years largely inferior to 50%. The diagnosis of several diseases, such as AML relies on invasive procedures. An increasing amount of evidence supports the straightforward relations between bone marrow (BM) biopsies and blood in hematological malignancies, including AML. Novel approaches to the characterization of TME have been developed. In this regard, scRNA-seq analysis emerged as a potent tool, capable of profoundly characterizing genomic profiles at the single-cell level. However, ST have the potential to improve our understanding of TME composition and cellular interactions, representing a powerful tool capable of identifying cell types and gene expression profiles on a structural and spatial level.
Since the question of a comprehensive characterization of tumor heterogeneity and cell-cell interactions is still unsolved, new ways to detect its modulation using blood are highly warranted for tumor diagnosing and monitoring. Indeed, conventional and invasive methods are insufficient to decipher the heterogeneous nature of tumors. Based on these premises, the driving hypothesis of the study is that performing an in-parallel analysis on both circulating cells and EVs might provide a broader characterization of the genomic landscape of tumors than using cells themselves. The integration of LB within the clinical management of cancer patients may represent an essential step towards a deeper understanding of cancer biology. It might have important implications for better disease monitoring and improved drug development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The planned population size for the study is 90 prospectively enrolled patients, 30 for each of the three study groups. No sample size calculations were performed due to the exploratory nature of this study.
Key inclusion criteria (13 listed)
- For HD:
- Age ≥ 18 years
- New diagnosis of AML according to World Health Organization 2022 criteria
- Front-line treatment according to routine clinical practice
- Signed written informed consent to study participation and personal data processing
Key exclusion criteria (6 listed)
- For HD:
- Acute promyelocytic leukemia (for AML)
- Known AML with central nervous system involvement (for AML)
- Visceral sarcoma in adjuvant setting (for sarcoma)
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
1. Malignant signals (cell subsets and EV markers)
Time frame: At diagnosis (T0)
The percentages of positive/negative cells for each marker and the markers' geometric means are measured by flow cytometry and defined by negative control or by the value detected by HD (group 1) versus AML or sarcoma patients (group 2-3).
1 secondary outcome
2. Transcriptomic profile in cells and EVs
Time frame: At diagnosis (T0)
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 8 Jan 2025.
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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.
Antonio Curti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myelocytic Leukemia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites 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 13 inclusion and 6 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
1. Malignant signals (cell subsets and EV markers) (time frame: At diagnosis (T0)). 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 8 Jan 2025.