Clinical trial NCT06097156: Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
Official title: Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Participants
Breast Cancer
Keywords: Breast Cancer
Metastatic Patients
Liquid Biopsy
Whole Blood
Plasma
White Blood Cells
Pre-Analytical Standardization
Lead sponsor: Tethis S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from among the people who visit the Breast department

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.

Detailed description: The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Evaluation of White Blood Cells adhered on SBS slides
timeFrame: 1 day (at the blood draw)
measure: SBS slides stability
timeFrame: 1 day (at the blood draw)]
measure: cfDNA quality control
timeFrame: 1 day (at the blood draw)
measure: Feasibility of using See.d SBS slides for subsequent analysis
timeFrame: 1 day (at the blood draw)
measure: Feasibility of using See.d plasma for subsequent analysis
timeFrame: 1 day (at the blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IEO
Study officials:
affiliation: IEO Hospital
name: Luca Mazzarella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.