Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

NCT06097156 | Recruiting

• 1 other identifier: TET-22-001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood. 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.

Conditions

Healthy Participants; Breast Cancer

Keywords

Breast Cancer; Metastatic Patients; Liquid Biopsy; Whole Blood; Plasma; White Blood Cells; Pre-Analytical Standardization

Outcome Measures

Primary Outcomes (5)

• Evaluation of White Blood Cells adhered on SBS slides

  Evaluation of total adhered cell count on SBS slides

  1 day (at the blood draw)

• SBS slides stability

  Evaluation of the area of adhered cell nuclei on SBS slides

  1 day (at the blood draw)]

• cfDNA quality control

  Evaluation of the ratio between cfDNA and genomic contaminant DNA

  1 day (at the blood draw)

• Feasibility of using See.d SBS slides for subsequent analysis

  Recovery of putative Circulating Tumor Cells (CTCs)

  1 day (at the blood draw)

• Feasibility of using See.d plasma for subsequent analysis

  Detection of already known DNA mutations

  1 day (at the blood draw)

Study Arms (2)

Healthy donors

Participants who are in good health and without history of cancer disease

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.

Eligibility Criteria

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

Study Population

Participants will be selected from among the people who visit the Breast department

You may qualify if:

• General (all participants)
• 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).

You may not qualify if:

• Ongoing infections requiring antibiotic or antiviral treatment
• 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)

Sponsors & Collaborators

• Tethis S.p.A.: lead

Study Sites (1)

IEO

Milan, 20132, Italy

RECRUITING

Related Publications (6)

• 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: clinicalguidelines@esmo.org. 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.

  PMID: 34678411 BACKGROUND

• 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.

  PMID: 29276709 BACKGROUND

• 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.

  PMID: 34756687 BACKGROUND

• 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.

  PMID: 33473219 BACKGROUND

• 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.

  PMID: 16504283 BACKGROUND

• 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.

  PMID: 33762721 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Luca Mazzarella, MD

  IEO Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Mazzarella, MD

CONTACT

+39 0294375111; luca.mazzarella@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)