Bronchial CancerNCT03328559
Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
A study testing ISET® - Isolation by Size of Tumor cells in people with Bronchial Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated. However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Cancer
- What is being tested?
- ISET® - Isolation by Size of Tumor cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2016to 20 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with non-small cell lung cancer
- accepting participation
Who cannot join
- refusing participation
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated.
However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment.
- Conditions
- Bronchial Cancer
- Being tested
- ISET® - Isolation by Size of Tumor cells
- Medical subject headings
- Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISET® - Isolation by Size of Tumor cellsDiagnostic test
early stage bronchial cancer patient will have a blood collection
ISET® - Isolation by Size of Tumor cellsDiagnostic test
advanced stage bronchial cancer patient will have a blood collection
| Study group | Role | What they receive |
|---|---|---|
| early stage bronchial cancer | Other | Early stage which can benefit from a surgical resection. A taking will be made in preoperative then in every consultation of follow-up after the intervention Receives: Diagnostic Test: ISET® - Isolation by Size of Tumor cells |
| advanced stage bronchial cancer | Other | Patients locally moved forward or at a metastatic stage handled by chemotherapy Receives: Diagnostic Test: ISET® - Isolation by Size of Tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeration of CTC (circulant tumoral cell)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start7 Mar 2016
- Primary completion30 Nov 2018
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean P Tredaniel, Pr, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328559
- Sponsor's protocol ID
- CTC
- Status last verified
- Aug 2021
- First submitted
- 23 Oct 2017
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
- ClinicalTrials.gov ID
- NCT03328559
- Acronym / sponsor ID
- CTC
- Conditions
- Bronchial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 1 Nov 2017 (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 pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated.
However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early stage bronchial cancer | Other | Diagnostic Test: ISET® - Isolation by Size of Tumor cellsEarly stage which can benefit from a surgical resection. A taking will be made in preoperative then in every consultation of follow-up after the intervention |
| advanced stage bronchial cancer | Other | Diagnostic Test: ISET® - Isolation by Size of Tumor cellsPatients locally moved forward or at a metastatic stage handled by chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with non-small cell lung cancer
- accepting participation
Key exclusion criteria (1 listed)
- refusing participation
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 |
|---|---|---|
| ISET® - Isolation by Size of Tumor cellsearly stage bronchial cancer patient will have a blood collection | Diagnostic test | early stage bronchial cancer |
| ISET® - Isolation by Size of Tumor cellsadvanced stage bronchial cancer patient will have a blood collection | Diagnostic test | advanced stage bronchial cancer |
Primary outcome
numeration of CTC (circulant tumoral cell)
Time frame: Day 1
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 23 Aug 2021.
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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.
Jean P Tredaniel, Pr principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISET® - Isolation by Size of Tumor cells in people with Bronchial Cancer, run by Fondation Hôpital Saint-Joseph 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 2 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: finished, as of the sponsor's last update on 23 Aug 2021. 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?
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?
numeration of CTC (circulant tumoral cell) (time frame: Day 1). 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 Aug 2021.