Liquid Micro-biopsy: a Novel Approach to Study Tumor Microenvironment From the Peripheral Blood

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 90
• From 16 Dec 2024 to the primary completion date, 31 Mar 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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