Metastatic Breast CancerCAPT CTCNCT06904625
Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
A study testing Taking blood samples before starting treatment in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Prostate Cancer
- What is being tested?
- Taking blood samples before starting treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2025to Nov 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+/HER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.
- Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
- Age ≥ 18 years and WHO ≤ 2
- Patient affiliated to Social Security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.
Who cannot join
- Associated pathology(ies) likely to prevent the study procedure from running smoothly
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
- Patient deprived of liberty or under legal protection (guardianship, legal protection)
- Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
IUCT-O
Toulouse
Florence DALENC, 05 31 15 51 22, Dalenc.florence@iuct-oncopole.fr
About this study
This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.
Each patient will participate in the study for one day.
A total of 54 evaluable patients (36 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.
- Being tested
- Taking blood samples before starting treatment
- Keywords
- Circulating Tumor Cell, Metastatic Prostate Cancer, Metastatic Breast Cancer, CellSearch®, Parsortix®, SmartCatch®
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking blood samples before starting treatmentOther
For patient included in the metastatic breast cancer and prostate cancer, a blood sample will be taken (37 mL in total) for the CTCs detection using the 3 technologies (CellSearch®, Parsortix® and SmartCatch®).
For 3 patients only, an additional blood volume (18 mL) will also be collected for tcDNA detection (exploratory analysis of 3 patients).
For patient included in the metastatic breast cancer complementary cohort, a blood sample will be taken (56 mL in total) for the CTCs detection using Parsortix® and SmartCatch® technologies.
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic breast cancer or prostate cancer | Other | Not described Receives: Other: Taking blood samples before starting treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
It is defined by the ratio of the number of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®) to the total number of patients.
Measured: 15 months after the study start
Secondary outcomes (2)
The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).
This is defined as the ratio of the number of patients with CTCs detected by the technique to the total number of patients.
Measured: 15 months after the study start
The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).
Measured: 15 months after the study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start14 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904625
- Sponsor's protocol ID
- 24GENE20
- Acronym
- CAPT CTC
- Status last verified
- May 2026
- First submitted
- 25 Mar 2025
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
- ClinicalTrials.gov ID
- NCT06904625
- Acronym / sponsor ID
- CAPT CTC / 24GENE20
- Keywords
- Circulating Tumor Cell, Metastatic Prostate Cancer, Metastatic Breast Cancer, CellSearch®, Parsortix®, SmartCatch®
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Apr 2025 (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 trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.
Each patient will participate in the study for one day.
A total of 54 evaluable patients (36 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic breast cancer or prostate cancer | Other | Other: Taking blood samples before starting treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+/HER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.
- Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
- Age ≥ 18 years and WHO ≤ 2
- Patient affiliated to Social Security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.
Key exclusion criteria (4 listed)
- Associated pathology(ies) likely to prevent the study procedure from running smoothly
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
- Patient deprived of liberty or under legal protection (guardianship, legal protection)
- Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.
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 |
|---|---|---|
| Taking blood samples before starting treatmentFor patient included in the metastatic breast cancer and prostate cancer, a blood sample will be taken (37 mL in total) for the CTCs detection using the 3 technologies (CellSearch®, Parsortix® and SmartCatch®). For 3 patients only, an additional blood volume (18 mL) will also be collected for tcDNA detection (exploratory analysis of 3 patients). For patient included in the metastatic breast cancer complementary cohort, a blood sample will be taken (56 mL in total) for the CTCs detection using Parsortix® and SmartCatch® technologies. | Other | Patients with metastatic breast cancer or prostate cancer |
Primary outcome
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
Time frame: 15 months after the study start
It is defined by the ratio of the number of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®) to the total number of patients.
2 secondary outcomes
The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).
Time frame: 15 months after the study start
The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).
Time frame: 15 months after the study start
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 27 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking blood samples before starting treatment in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Institut Claudius Regaud at 1 site in France.
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 5 inclusion and 4 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 27 May 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 France. 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 Florence DALENC (05 31 15 51 22, Dalenc.florence@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®). (time frame: 15 months after the study start). 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 27 May 2026.