Locally Advanced Breast CancerCTCNeoBCNCT03732339
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial
A study testing GILUPI CellCollector® in people with Locally Advanced Breast Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
Trial summary
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer, Circulating Tumor Cell
- What is being tested?
- GILUPI CellCollector®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
- ECOG 0-1
- Adequate organ function
- Consent to undergo CTC analysis in vivo
Who cannot join
- Pregnant or breastfeeding patients
- Metastatic or recurrent patients
- Uncontrollable infection
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.
- Being tested
- GILUPI CellCollector®
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GILUPI CellCollector®Device
Use of GILUPI CellCollector® to detect CTC
| Study group | Role | What they receive |
|---|---|---|
| GILUPI CellCollector® | Experimental | Not described Receives: Device: GILUPI CellCollector® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of CTC in ypT0 ypN0
Measured: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
Secondary outcomes (3)
Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR
Measured: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
hypersensitivity
Number of participants with hypersensitivity as assessed by CTCAE v4.0
Measured: up to 1 year
Detection rate of GILUPI CellCollector®
Measured: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start24 Aug 2018
- Primary completion11 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Viroad Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Jinsong Lu, RenJi Hospital
- Investigators
- Jinsong Lu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732339
- Sponsor's protocol ID
- RenJiH-2018-038
- Acronym
- CTCNeoBC
- Status last verified
- Apr 2022
- First submitted
- 8 Oct 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT03732339
- Acronym / sponsor ID
- CTCNeoBC / RenJiH-2018-038
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Beijing Viroad Biotechnology Co., Ltd.
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Nov 2018 (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 GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GILUPI CellCollector® | Experimental | Device: GILUPI CellCollector® |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
- ECOG 0-1
- Adequate organ function
- Consent to undergo CTC analysis in vivo
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding patients
- Metastatic or recurrent patients
- Uncontrollable infection
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 |
|---|---|---|
| GILUPI CellCollector®Use of GILUPI CellCollector® to detect CTC | Device | GILUPI CellCollector® |
Primary outcome
Predictive value of CTC in ypT0 ypN0
Time frame: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
3 secondary outcomes
Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR
Time frame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
hypersensitivity
Time frame: up to 1 year
Detection rate of GILUPI CellCollector®
Time frame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jinsong Lu principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GILUPI CellCollector® in people with Locally Advanced Breast Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive value of CTC in ypT0 ypN0 (time frame: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy). 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 29 Apr 2022.