Stage IIIB Non Small Cell Lung CancerCIRCUBRONCHNCT01658332
Circulating Tumor Cells in Lung Cancer
A study testing blood samples in people with Stage IIIB Non Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH) BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IIIB Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
- Age ≥ 18 years.
- Measurable or evaluable disease according to RECIST criteria.
- Ability to sign informed consent.
Who cannot join
- Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
- Prior chemotherapy, radiation or surgery for lung cancer.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)
BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.
Read more
PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).
SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.
STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
Duration of the inclusions: 54 months.
Duration of the study: 66 months.
PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.
SAMPLE SIZE : 200 patients
STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.
- Being tested
- blood samples
- Keywords
- lung cancer, circulating tumor cells, prospective, monocentrique trial
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
3 tubes (15 ml)
| Study group | Role | What they receive |
|---|---|---|
| specific procedure | Experimental | Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.
Measured: 18 months
Secondary outcomes (1)
Identification of a cellular profile according to clinical factors (sex,histology, …).
epidemiological,and clinical characteristics of patients with advanced lung cancer
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: unavailability of the investigator due to an overloaded planning
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Non Small Cell Lung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle CLEMENT-DUCHENE, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658332
- Sponsor's protocol ID
- 2012-A00135-38
- Acronym
- CIRCUBRONCH
- Status last verified
- Jul 2015
- First submitted
- 16 Jun 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01658332
- Acronym / sponsor ID
- CIRCUBRONCH / 2012-A00135-38
- Keywords
- lung cancer, circulating tumor cells, prospective, monocentrique trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unavailability of the investigator due to an overloaded planning
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Aug 2012 (estimated)
- 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.
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)
BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.
PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).
SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.
STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
Duration of the inclusions: 54 months.
Duration of the study: 66 months.
PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.
SAMPLE SIZE : 200 patients
STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| specific procedure | Experimental | Other: blood samplesCirculating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
- Age ≥ 18 years.
- Measurable or evaluable disease according to RECIST criteria.
- Ability to sign informed consent.
Key exclusion criteria (3 listed)
- Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
- Prior chemotherapy, radiation or surgery for lung cancer.
- Inability to comply with study and/or follow-up procedures.
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 samples3 tubes (15 ml) | Other | specific procedure |
Primary outcome
Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
Time frame: 18 months
Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.
1 secondary outcome
Identification of a cellular profile according to clinical factors (sex,histology, …).
Time frame: 18 months
Results and safety
The study was stopped early (reason given: unavailability of the investigator due to an overloaded planning). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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RecruitingPhase 3
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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.
Christelle CLEMENT-DUCHENE, MD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Stage IIIB Non Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, run by Central Hospital, Nancy, France 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 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: stopped early, as of the sponsor's last update on 30 Jul 2015. 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 was stopped early (reason given: unavailability of the investigator due to an overloaded planning). Results are not available in the source record.
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?
Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer. (time frame: 18 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 30 Jul 2015.