Breast CancerBioCellPheNCT06048835
Circulating Tumour Cells Characterization in Breast Cancer Patients
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood sample
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 31 Dec 2028
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study involves female patients with diagnosis of early-breast cancer candidate for surgery and female patients with diagnosis of metastatic breast cancer. A control group of sex and age matched healthy volunteers, not affected by any neoplastic disease will be enrolled too.
Who may be able to join
- female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams.
- female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation.
- patients not affected by any neoplastic disease.
Who cannot join
- Diagnosis of any neoplastic disease
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
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, 27100
Fabio Corsi, Professor, 0382592272, fabio.corsi@icsmaugeri.it
Carlo Morasso, PhD, carlo.morasso@icsmaugeri.it
About this study
Official title: Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level
In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate the customization of personalized treatments. However, detecting CTCs in breast cancer patients presents complexities due to their substantial phenotypic heterogeneity and typically low concentration.
Numerous approaches have been developed for CTC detection. Nonetheless, the currently available technologies remain intricate, time-consuming, and costly. The BioCellPhe Project is dedicated to the development of a novel device capable of isolating and characterizing individual CTCs. This innovative device relies on the identification of specific cell membrane proteins with remarkable precision, achieved through the application of novel orthogonal techniques.
On one hand, engineered bacteria are utilized to precisely bind to membrane proteins of interest on CTCs. On the other hand, Surface Enhanced Raman Spectroscopy (SERS) is employed for the detection of individual molecules. Specifically, the BioCellPhe Project focuses on comprehensively studying CTCs in breast cancer patients, encompassing both metastatic and non-metastatic cases.
Read the detailed description
This is an experimental, prospective and monocentric study. This study involves consecutive patients with diagnosis of breast cancer (BC), including early breast cancer and metastatic breast cancer patients, referring to the Breast Unit and to the Oncology Department at Istituti Clinici Scientifici Maugeri, Pavia (Italy).
Patients diagnosed with different histological types of breast cancer will be enrolled in the study: luminal BC, HER2-enriched BC, triple-negative BC.
The study duration is 24 months, starting from December 2022 to December 2024.
The patients will be divided into three groups, as follows:
- Population 1: patients diagnosed with metastatic breast cancer.
- Population 2: patients diagnosed with primary early-breast cancer candidate for surgery.
- Population 3: a control group of sex and age matched healthy volunteers, not affected by any neoplastic disease.
For each patient, a 15 ml EDTA blood sample will be collected at different time-points, as follows:
- Population 1: before starting a potential chemotherapy treatment.
- Population 2: before undergoing surgical procedure.
- Population 3: at the first useful moment. The blood samples will be collected at the Maugeri Institute and CTCs will be isolated within 48 hours to validate the device.
For each patient, the following clinico-anamnestic information will be collected: age, histological tumour information at diagnosis (tumour subtype, grading, receptors' status, Ki-67 value), histological metastases information, clinical stage (clinical TNM), type of surgery, pathological staging after surgery (pTNM).
- Conditions
- Breast Cancer
- Being tested
- Blood sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDevice
For each patient, a 15 ml EDTA blood sample will be collected at different time-points
| Study group | Role | What they receive |
|---|---|---|
| MBC | Patients diagnosed with metastatic breast cancer Receives: Device: Blood sample | |
| EBC | Patients diagnosed with primary early-breast cancer candidate for surgery Receives: Device: Blood sample | |
| HC | Control group of sex and age matched healthy volunteers, not affected by any neoplastic disease Receives: Device: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect specific proteins on CTCs in breast cancer patients
Clinical validation of a new technological device able to detect specific target surface proteins on CTCs in breast cancer patients, both non-metastatic and metastatic.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2022
- Primary completion30 Sep 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Carlo Morasso
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048835
- Sponsor's protocol ID
- 2684
- Acronym
- BioCellPhe
- Status last verified
- May 2026
- First submitted
- 15 Sep 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level
- ClinicalTrials.gov ID
- NCT06048835
- Acronym / sponsor ID
- BioCellPhe / 2684
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Carlo Morasso
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Sep 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.
In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate the customization of personalized treatments. However, detecting CTCs in breast cancer patients presents complexities due to their substantial phenotypic heterogeneity and typically low concentration.
Numerous approaches have been developed for CTC detection. Nonetheless, the currently available technologies remain intricate, time-consuming, and costly. The BioCellPhe Project is dedicated to the development of a novel device capable of isolating and characterizing individual CTCs. This innovative device relies on the identification of specific cell membrane proteins with remarkable precision, achieved through the application of novel orthogonal techniques.
On one hand, engineered bacteria are utilized to precisely bind to membrane proteins of interest on CTCs. On the other hand, Surface Enhanced Raman Spectroscopy (SERS) is employed for the detection of individual molecules. Specifically, the BioCellPhe Project focuses on comprehensively studying CTCs in breast cancer patients, encompassing both metastatic and non-metastatic cases.
Detailed description
This is an experimental, prospective and monocentric study. This study involves consecutive patients with diagnosis of breast cancer (BC), including early breast cancer and metastatic breast cancer patients, referring to the Breast Unit and to the Oncology Department at Istituti Clinici Scientifici Maugeri, Pavia (Italy).
Patients diagnosed with different histological types of breast cancer will be enrolled in the study: luminal BC, HER2-enriched BC, triple-negative BC.
The study duration is 24 months, starting from December 2022 to December 2024.
The patients will be divided into three groups, as follows:
- Population 1: patients diagnosed with metastatic breast cancer.
- Population 2: patients diagnosed with primary early-breast cancer candidate for surgery.
- Population 3: a control group of sex and age matched healthy volunteers, not affected by any neoplastic disease.
For each patient, a 15 ml EDTA blood sample will be collected at different time-points, as follows:
- Population 1: before starting a potential chemotherapy treatment.
- Population 2: before undergoing surgical procedure.
- Population 3: at the first useful moment. The blood samples will be collected at the Maugeri Institute and CTCs will be isolated within 48 hours to validate the device.
For each patient, the following clinico-anamnestic information will be collected: age, histological tumour information at diagnosis (tumour subtype, grading, receptors' status, Ki-67 value), histological metastases information, clinical stage (clinical TNM), type of surgery, pathological staging after surgery (pTNM).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBC | – | Device: Blood samplePatients diagnosed with metastatic breast cancer |
| EBC | – | Device: Blood samplePatients diagnosed with primary early-breast cancer candidate for surgery |
| HC | – | Device: Blood sampleControl group of sex and age matched healthy volunteers, not affected by any neoplastic disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study involves female patients with diagnosis of early-breast cancer candidate for surgery and female patients with diagnosis of metastatic breast cancer. A control group of sex and age matched healthy volunteers, not affected by any neoplastic disease will be enrolled too.
Key inclusion criteria (3 listed)
- female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams.
- female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation.
- patients not affected by any neoplastic disease.
Key exclusion criteria (1 listed)
- Diagnosis of any neoplastic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleFor each patient, a 15 ml EDTA blood sample will be collected at different time-points | Device | EBC, HC, MBC |
Primary outcome
Detect specific proteins on CTCs in breast cancer patients
Time frame: 24 months
Clinical validation of a new technological device able to detect specific target surface proteins on CTCs in breast cancer patients, both non-metastatic and metastatic.
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA 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 3 inclusion and 1 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 23 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect specific proteins on CTCs in breast cancer patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.