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

Tethis

Status: Enrolling

Conditions: Breast Cancer; Healthy Participants

Study type: Observational

Funder types: Industry

Identifiers

NCT06097156

TET-22-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

45 participants in 2 patient groups

Healthy donors

Description:

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

Metastatic Breast Cancer patients

Description:

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.