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

NCT06764589 | Active Not Recruiting

• 1 other identifier: MICRO-biopsy
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Acute Myelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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).

  At diagnosis (T0)

Secondary Outcomes (1)

• 2. Transcriptomic profile in cells and EVs

  At diagnosis (T0)

Other Outcomes (2)

• 3. Tissue characterization and spatial profiling

  At diagnosis (T0)

• 4. Clinical response prediction for AML and sarcoma patients from LB or spatial data

  At diagnosis (T0) At the first response evaluation after therapy, according to routine clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

IRCCS Azienda-Ospedaliero Universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Periferal blood, Bone marrow aspirate and bone marrow biopsy

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Antonio Curti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: December 16, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 2, 2027
• Last Updated: January 8, 2025

Record last verified: 2024-12

Locations

IT (2)