Invasive Breast CancerPDO-MercurialNCT07421479
Patient-Derived Breast Cancer Organoids for Therapeutic Extracellular Vesicle Isolation (PDO-Mercurial01)
An observational study of Invasive Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer
- What is being tested?
- Blood and tumor tissue collection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 28 Oct 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients consecutively referred to the Breast Unit of the IRCCS ICS Maugeri in Pavia who have breast neoplasm will be included in the study.
Who may be able to join
- Female subjects;
- Confirmed diagnosis of breast heteroplasia
- Age >= 18 years;
- Patients willing to follow the usual oncological follow-up;
- Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy;
- Subjects who agree to participate in the study by signing and dating the Informed Consent form.
Who cannot join
- Patients without a proven cyto-histological diagnosis of breast carcinoma;
- Subjects affected by other solid tumors besides the breast lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Single-center Study for the Generation of Organoids From Patients With Breast Carcinoma for Use in Extracellular Vesicle Isolation
The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. These organoids will be used for the isolation of extracellular vesicles (EVs), which are naturally released by cells and have the ability to selectively recognize tumor tissue. Due to these properties, EVs represent promising vectors for the targeted delivery of diagnostic agents, with potential applications in fluorescence-guided surgery.
Read the detailed description
Breast cancer is the leading cause of cancer-related mortality among European women. Despite advances in diagnosis and treatment, disease recurrence and therapy resistance remain major challenges. Improving the specific visualization of tumor tissue is essential to support precision medicine approaches and enable more accurate surgical resections.
Extracellular vesicles (EVs), naturally released by cells, have shown the ability to selectively recognize tumor tissue and represent promising vectors for targeted delivery of diagnostic agents. However, their clinical application is currently limited by the lack of reliable and representative sources. This project proposes the use of patient-derived organoids (PDOs) as a controlled and patient-specific source of EVs to better study their biological functions and diagnostic potential.
PDOs are accurate and personalized three-dimensional tumor models that recapitulate the biological and clinical characteristics of individual breast cancers. Differences between tumor-derived and healthy tissue samples will also be explored.
This prospective, single-center, observational study will recruit breast cancer patients undergoing surgery at IRCCS ICS Maugeri (Pavia). Clinical and pathological data will be collected prospectively, along with a 5-year follow-up to monitor disease recurrence and treatments. Organoids will be generated from surgical specimens to isolate EVs, which will be investigated as delivery systems for indocyanine green fluorescent contrast agents in FGS applications. No additional clinical procedures or blood samples beyond standard care are required.
- Conditions
- Invasive Breast Cancer
- Being tested
- Blood and tumor tissue collection
- Keywords
- Triple Negative Breast Cancer, Patient-Derived Organoids, Extracellular Vesicles
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tumor tissue collectionProcedure or surgery
This prospective multicenter and observational study aims to recruit breast cancer patients who are candidates for surgery.After obtaining written and verbal informed consent, the following clinical and anamnestic data will be prospectively collected for each patient: age, comorbidities, type of breast lesion, lesion size assessed by imaging and post-operative histopathology, histological type, TNM disease stage, tumor grade, and biomolecular profile. In addition, follow-up data will be collected for each patient, including type of surgical procedure, type of treatment, and final histological report. Follow-up will extend for five years after surgery and will include information on any disease recurrence and subsequent treatments. rganoid cultures will be generated from surgical specimens to isolate extracellular vesicles (EVs) and evaluate their potential as delivery systems for indocyanine green in fluorescence-guided surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of Patient-Derived Organoids of Breast Cancer
Number and proportion of patients from which Patient-Derived Organoids lines will be succesfully established from collected tumor tissue samples
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2025
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421479
- Sponsor's protocol ID
- PDO-Mercurial 01 - CTSPV66-25
- Acronym
- PDO-Mercurial
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-center Study for the Generation of Organoids From Patients With Breast Carcinoma for Use in Extracellular Vesicle Isolation
- ClinicalTrials.gov ID
- NCT07421479
- Acronym / sponsor ID
- PDO-Mercurial / PDO-Mercurial 01 - CTSPV66-25
- Conditions
- Invasive Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Patient-Derived Organoids, Extracellular Vesicles
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. These organoids will be used for the isolation of extracellular vesicles (EVs), which are naturally released by cells and have the ability to selectively recognize tumor tissue. Due to these properties, EVs represent promising vectors for the targeted delivery of diagnostic agents, with potential applications in fluorescence-guided surgery.
Detailed description
Breast cancer is the leading cause of cancer-related mortality among European women. Despite advances in diagnosis and treatment, disease recurrence and therapy resistance remain major challenges. Improving the specific visualization of tumor tissue is essential to support precision medicine approaches and enable more accurate surgical resections.
Extracellular vesicles (EVs), naturally released by cells, have shown the ability to selectively recognize tumor tissue and represent promising vectors for targeted delivery of diagnostic agents. However, their clinical application is currently limited by the lack of reliable and representative sources. This project proposes the use of patient-derived organoids (PDOs) as a controlled and patient-specific source of EVs to better study their biological functions and diagnostic potential.
PDOs are accurate and personalized three-dimensional tumor models that recapitulate the biological and clinical characteristics of individual breast cancers. Differences between tumor-derived and healthy tissue samples will also be explored.
This prospective, single-center, observational study will recruit breast cancer patients undergoing surgery at IRCCS ICS Maugeri (Pavia). Clinical and pathological data will be collected prospectively, along with a 5-year follow-up to monitor disease recurrence and treatments. Organoids will be generated from surgical specimens to isolate EVs, which will be investigated as delivery systems for indocyanine green fluorescent contrast agents in FGS applications. No additional clinical procedures or blood samples beyond standard care are required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients consecutively referred to the Breast Unit of the IRCCS ICS Maugeri in Pavia who have breast neoplasm will be included in the study.
Key inclusion criteria (6 listed)
- Female subjects;
- Confirmed diagnosis of breast heteroplasia
- Age >= 18 years;
- Patients willing to follow the usual oncological follow-up;
- Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy;
Key exclusion criteria (2 listed)
- Patients without a proven cyto-histological diagnosis of breast carcinoma;
- Subjects affected by other solid tumors besides the breast lesion.
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 and tumor tissue collectionThis prospective multicenter and observational study aims to recruit breast cancer patients who are candidates for surgery.After obtaining written and verbal informed consent, the following clinical and anamnestic data will be prospectively collected for each patient: age, comorbidities, type of breast lesion, lesion size assessed by imaging and post-operative histopathology, histological type, TNM disease stage, tumor grade, and biomolecular profile. In addition, follow-up data will be collected for each patient, including type of surgical procedure, type of treatment, and final histological report. Follow-up will extend for five years after surgery and will include information on any disease recurrence and subsequent treatments. rganoid cultures will be generated from surgical specimens to isolate extracellular vesicles (EVs) and evaluate their potential as delivery systems for indocyanine green in fluorescence-guided surgery. | Procedure or surgery | – |
Primary outcome
Establishment of Patient-Derived Organoids of Breast Cancer
Time frame: 36 months
Number and proportion of patients from which Patient-Derived Organoids lines will be succesfully established from collected tumor tissue samples
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 19 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Invasive 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of Patient-Derived Organoids of Breast Cancer (time frame: 36 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 19 Feb 2026.