Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
NCT ID: NCT06097156
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2023-11-06
2025-06-30
Brief Summary
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Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.
Detailed Description
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Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters.
Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC).
For its feasibility nature, no formal statistics has been planned for this study.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy donors
Participants who are in good health and without history of cancer disease
No interventions assigned to this group
Metastatic Breast Cancer patients
Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants is willing and able to give and sign a written informed consent
* Aged 18 or above
* Specific for metastatic breast cancer patients
* Female for metastatic breast cancer patients, aged 18 or above
* Histological confirmation of breast cancer
* Presence of at least one non-bone metastasis
* Disease assessed to be in clinical or radiologic progression to the last line of treatment, as evaluated by the investigator
* The biopsy, when recommended by the oncologist, is scheduled within 4 weeks after the date of blood withdrawal
* Last biopsy or any other minor surgical procedure was perfomed at least 7 days before blood withdrawal
* Known Bilirubin level ≥ 2 mg/dL on a blood sample collected within 7 days from the enrolment. If unavailable, it is not necessary to assess bilirubin
* Specific for healthy participants
* Both sexes for healthy volunteers, aged 18 or above
* Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).
Exclusion Criteria
* Previous history of a blood cancer or an invasive non-BC apart from cancers treated with curative intent at least 3 years previously with no recurrence since diagnosis with the exception of non-melanoma skin cancer. For healthy participants also includes breast cancer
* Undergone major surgery \< 4 weeks prior to the time of blood collection
* Initiated a new line of treatment after disease progression at the time of blood or tissue biopsy collection
* Presence of known severe coagulation or haematological disorder
* Pregnancy
* For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)
18 Years
ALL
Yes
Sponsors
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Tethis S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Luca Mazzarella, MD
Role: PRINCIPAL_INVESTIGATOR
IEO Hospital
Locations
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IEO
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Luca Mazzarella, MD
Role: primary
References
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Gennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: [email protected]. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available.
Turashvili G, Brogi E. Tumor Heterogeneity in Breast Cancer. Front Med (Lausanne). 2017 Dec 8;4:227. doi: 10.3389/fmed.2017.00227. eCollection 2017.
Seale KN, Tkaczuk KHR. Circulating Biomarkers in Breast Cancer. Clin Breast Cancer. 2022 Apr;22(3):e319-e331. doi: 10.1016/j.clbc.2021.09.006. Epub 2021 Sep 22.
Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol. 2021 May;18(5):297-312. doi: 10.1038/s41571-020-00457-x. Epub 2021 Jan 20.
Carbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podesta A, Fiorentini F, Bongiorno G, Piseri P, Pelicci PG, Milani P. Biocompatibility of cluster-assembled nanostructured TiO2 with primary and cancer cells. Biomaterials. 2006 Jun;27(17):3221-9. doi: 10.1016/j.biomaterials.2006.01.056. Epub 2006 Feb 28.
Krol I, Schwab FD, Carbone R, Ritter M, Picocci S, De Marni ML, Stepien G, Franchi GM, Zanardi A, Rissoglio MD, Covelli A, Guidi G, Scarinci D, Castro-Giner F, Mazzarella L, Doglioni C, Borghi F, Milani P, Kurzeder C, Weber WP, Aceto N. Detection of clustered circulating tumour cells in early breast cancer. Br J Cancer. 2021 Jul;125(1):23-27. doi: 10.1038/s41416-021-01327-8. Epub 2021 Mar 24.
Other Identifiers
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TET-22-001
Identifier Type: -
Identifier Source: org_study_id