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

December 1, 2023 updated by: Tethis S.p.A.

Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • General (all participants)

    • Participants is willing and able to give and sign a written informed consent
    • Aged 18 or above
    • Blood parameters if available (hematology: complete blood count, kidney and liver function, total protein and albumin, coagulation, etc)

  • 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 and reported in the CaseReport Form
    • The biopsy can be scheduled for <4 weeks after the date of blood withdrawal
    • Blood sampling must be performed at least later than 7 days after the last biopsy or any other minor surgical procedure

  • 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
  • History of other malignancies other than breast cancer (for healthy participants also includes breast cancer).
  • Undergone major surgery or treatment for breast cancer (including endocrine, targeted, radio- or chemotherapy) <4 weeks before enrolment
  • Presence of known severe coagulation or haematological disorder
  • Pregnancy
  • For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Healthy donors
Participants who are in good health and without history of cancer disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cfDNA quality control
Time Frame: 1 day (at the blood draw)
Evaluation of the ratio between cfDNA and genomic contaminant DNA
1 day (at the blood draw)
Evaluation of White Blood Cells adhered on SBS slides
Time Frame: 1 day (at the blood draw)
Evaluation of total adhered cell count on SBS slides
1 day (at the blood draw)
SBS slides stability
Time Frame: 1 day (at the blood draw)]
Evaluation of the area of adhered cell nuclei on SBS slides
1 day (at the blood draw)]
Feasibility of using See.d SBS slides for subsequent analysis
Time Frame: 1 day (at the blood draw)
Recovery of putative Circulating Tumor Cells (CTCs)
1 day (at the blood draw)
Feasibility of using See.d plasma for subsequent analysis
Time Frame: 1 day (at the blood draw)
Detection of already known DNA mutations
1 day (at the blood draw)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tethis S.p.A.

Investigators

  • Principal Investigator: Luca Mazzarella, MD, IEO Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TET-22-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a preliminary research study without an IPD information sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe