Healthy ParticipantsNCT06097156
Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
An observational study of Healthy Participants and Breast Cancer, run by Tethis S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from among the people who visit the Breast department
Who may be able to join
- 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
Show all 14Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IEO
Milan, 20132
Luca Mazzarella, MD, +39 0294375111, luca.mazzarella@ieo.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants, Breast Cancer
- Keywords
- Breast Cancer, Metastatic Patients, Liquid Biopsy, Whole Blood, Plasma, White Blood Cells, Pre-Analytical Standardization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of White Blood Cells adhered on SBS slides
Evaluation of total adhered cell count on SBS slides
Measured: 1 day (at the blood draw)
SBS slides stability
Evaluation of the area of adhered cell nuclei on SBS slides
Measured: 1 day (at the blood draw)]
cfDNA quality control
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Measured: 1 day (at the blood draw)
Feasibility of using See.d SBS slides for subsequent analysis
Recovery of putative Circulating Tumor Cells (CTCs)
Measured: 1 day (at the blood draw)
Feasibility of using See.d plasma for subsequent analysis
Detection of already known DNA mutations
Measured: 1 day (at the blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start6 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tethis S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Mazzarella, MD, Principal investigator, IEO Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097156
- Sponsor's protocol ID
- TET-22-001
- Status last verified
- Jan 2026
- First submitted
- 18 Oct 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a preliminary research study without an IPD information sharing plan
Publications
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.
PubMed 34678411Turashvili G, Brogi E. Tumor Heterogeneity in Breast Cancer. Front Med (Lausanne). 2017 Dec 8;4:227. doi: 10.3389/fmed.2017.00227. eCollection 2017.
PubMed 29276709Seale 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.
PubMed 34756687Ignatiadis 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.
PubMed 33473219Carbone 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.
PubMed 16504283Krol 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.
PubMed 33762721
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications
- ClinicalTrials.gov ID
- NCT06097156
- Acronym / sponsor ID
- TET-22-001
- Conditions
- Healthy Participants, Breast Cancer
- Keywords
- Breast Cancer, Metastatic Patients, Liquid Biopsy, Whole Blood, Plasma, White Blood Cells, Pre-Analytical Standardization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tethis S.p.A.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from among the people who visit the Breast department
Key inclusion criteria (14 listed)
- General (all participants)
- Specific for metastatic breast cancer patients
- Specific for healthy participants
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
SBS slides stability
Time frame: 1 day (at the blood draw)]
Evaluation of the area of adhered cell nuclei on SBS slides
cfDNA quality control
Time frame: 1 day (at the blood draw)
Evaluation of the ratio between cfDNA and genomic contaminant DNA
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)
Feasibility of using See.d plasma for subsequent analysis
Time frame: 1 day (at the blood draw)
Detection of already known DNA mutations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 34678411Gennari 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.
- Background: PubMed 29276709Turashvili G, Brogi E. Tumor Heterogeneity in Breast Cancer. Front Med (Lausanne). 2017 Dec 8;4:227. doi: 10.3389/fmed.2017.00227. eCollection 2017.
- Background: PubMed 34756687Seale 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.
- Background: PubMed 33473219Ignatiadis 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.
- Background: PubMed 16504283Carbone 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.
- Background: PubMed 33762721Krol 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.
- Individual participant dataSharing planned: No. This is a preliminary research study without an IPD information sharing plan
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Mazzarella, MD principal investigator
IEO Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Participants and Breast Cancer, run by Tethis S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Mazzarella, MD (+39 0294375111, luca.mazzarella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of White Blood Cells adhered on SBS slides (time frame: 1 day (at the blood draw)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097156, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.