Non Small Cell Lung CancerEVIEPEBNCT00960271
Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- EBUS
- Type of treatment
- Surgery or procedure
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Dec 2011
- Phase
- Observational
- 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
Study population: This study will include non small cell lung cancer patients, stage III A (before PET Scan), with resectable tumors.
Who may be able to join
- adult patients over 18
- non small cell lung cancer histologically or cytologically proved
- Clinical Stage IIIA
- anatomically and functionally resectable
Who cannot join
- uncorrected bleeding disorders
- absence of lymphadenopathy superior to 1cm in small axis at CT scan
- contraindication to bronchoscopy
- extrathoracic or intrathoracic metastasis
- respiratory function tests not compatible with curative resection of lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- EBUS
- Keywords
- Non-small cell lung cancer, mediastinal lymph node, resectable, EBUS, stage IIIA, significant mediastinal lymph node at thoracic CT Scan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUSProcedure or surgery
Also called NSCLC
a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time
| Study group | Role | What they receive |
|---|---|---|
| NON SMALL CELL LUNG CANCER | Non small cell lung cancer, with clinical N2 disease, otherwise operable. Receives: Procedure: EBUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mediastinoscopy avoided
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960271
- Sponsor's protocol ID
- 2007/138/HP
- Other IDs
- EVIEPEB
- Acronym
- EVIEPEB
- Status last verified
- Jan 2013
- First submitted
- 14 Aug 2009
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chouaid C, Salaun M, Gounant V, Febvre M, Vergnon JM, Jouniaux V, Fournier C, Lachkar S, Hermant C, Raspaud C, Quantin X, Quiot JJ, Molard A, Dayen C, Marquette CH, Lena H, Zalcman G, Thiberville L. Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB). PLoS One. 2019 Jan 7;14(1):e0208992. doi: 10.1371/journal.pone.0208992. eCollection 2019.
PubMed 30615623
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
- ClinicalTrials.gov ID
- NCT00960271
- Acronym / sponsor ID
- EVIEPEB / 2007/138/HP
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, mediastinal lymph node, resectable, EBUS, stage IIIA, significant mediastinal lymph node at thoracic CT Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 2009 (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.
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NON SMALL CELL LUNG CANCER | – | Procedure: EBUSNon small cell lung cancer, with clinical N2 disease, otherwise operable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include non small cell lung cancer patients, stage III A (before PET Scan), with resectable tumors.
Key inclusion criteria (4 listed)
- adult patients over 18
- non small cell lung cancer histologically or cytologically proved
- Clinical Stage IIIA
- anatomically and functionally resectable
Key exclusion criteria (5 listed)
- uncorrected bleeding disorders
- absence of lymphadenopathy superior to 1cm in small axis at CT scan
- contraindication to bronchoscopy
- extrathoracic or intrathoracic metastasis
- respiratory function tests not compatible with curative resection of lung cancer
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 |
|---|---|---|
| EBUSAlso: NSCLCa minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time | Procedure or surgery | NON SMALL CELL LUNG CANCER |
Primary outcome
number of mediastinoscopy avoided
Time frame: 24h
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 18 Jan 2013.
- Derived from this study: PubMed 30615623Chouaid C, Salaun M, Gounant V, Febvre M, Vergnon JM, Jouniaux V, Fournier C, Lachkar S, Hermant C, Raspaud C, Quantin X, Quiot JJ, Molard A, Dayen C, Marquette CH, Lena H, Zalcman G, Thiberville L. Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB). PLoS One. 2019 Jan 7;14(1):e0208992. doi: 10.1371/journal.pone.0208992. eCollection 2019.
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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 Non Small Cell Lung Cancer, run by University Hospital, Rouen 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 5 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 18 Jan 2013. 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?
number of mediastinoscopy avoided (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960271, which also lists 1 linked publication.
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 18 Jan 2013.