Non-small Cell Lung CancerCLIPPCAIRNCT03885765
Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping
An observational study of Non-small Cell Lung Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The primary objective of the CLIPPCAIR study is to construct and validate a new algorithm for predicting post-operative forced expiratory volume in 1 second (FEV1) values for lung resection candidates; this new model will be based on data derived from a thoracic CT scan with injection of contrast media. 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?
- Predictive data and Lung resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2020to 18 Apr 2025
- 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: The targeted study population corresponds to non-small cell lung cancer patients requiring pulmonary excision and who need to update their computed tomography scan data (CT scan) prior to surgery.
Who may be able to join
- Patient diagnosed with non-small cell lung cancer
- Indication for pulmonary excision surgery
- Patient requiring a more recent pre-surgical computed tomography scan (CT scan)
- The patient has been correctly informed about the study and has signed the consent form
- The patient is affiliated with or a beneficiary of the French single-payer social security programme (national health insurance)
Who cannot join
- Patient in an exclusion period determined by another protocol
- Participation in another study that may affect the results of the present study (anti-cancer treatment studies are allowed)
- Patient under legal or judicial protection
- Contraindication to surgery or iodine injection
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR): Protocol for the Development and Validation of a Novel Algorithm for Post-resection Lung Function
The primary objective of the CLIPPCAIR study is to construct and validate a new algorithm for predicting post-operative forced expiratory volume in 1 second (FEV1) values for lung resection candidates; this new model will be based on data derived from a thoracic CT scan with injection of contrast media.
Read the detailed description
Secondarily, the predictions made using traditional scintigraphic data will be compared with those from the new algorithm in a subset of high-risk patients, and cumulative contrast media and irradiation doses associated with imaging will be presented. How other measures of pulmonary function (e.g. transfer factor of the lung for carbon monoxide (TLCO)) and the presence/absence of operative complications might be predicted will also be investigated. Additionally, the potential links between (i) pre-surgical imaging data, (ii) post-surgical changes in respiratory function, and (iii) changes in health related quality of life will also be explored.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Predictive data, Lung resection
- 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.
Predictive dataDiagnostic test
The novel predictive data in this study includes 5 predefined variables derived from thoracic CT scans:
(i) Expiratory to inspiratory ratio of mean lung density (MLDe/i), total; (ii) MLDe/i of the section to be excised / MLDe/i total; (iii) Percentage of emphysema according to voxel thresholding at -950 HU (PVOX-950), total; (iv) PVOX-950 for the section to be excised; (v) Iodine concentration [I] of the section to be excised / [I] total.
Lung resectionProcedure or surgery
Surgical resection will be characterised by type (pneumonectomy, bi-lobectomy, lobectomy, or lobectomy with anastomosis resection), whether or not lymph node dissection was performed, and whether or not the resection was atypical.
| Study group | Role | What they receive |
|---|---|---|
| Test group | The first 60 patients recruited. Receives: Diagnostic Test: Predictive data; Procedure: Lung resection | |
| Validation group | The last 100 patients recruited. Receives: Diagnostic Test: Predictive data; Procedure: Lung resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1) from spirometry
Measured: 6 months
Correlation between predicted and real values for post-surgical FEV1
Measured: 6 months
Secondary outcomes (26)
Estimated post-operative FEV1 (litres) according to scintigraphy
Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy
Measured: Baseline (day 0)
Estimated post-operative TLCO according to scintigraphy
estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution
Measured: Baseline (day 0)
Estimated post-operative FEV1 according segment counting (1)
FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised
Measured: Baseline (day 0)
Estimated post-operative FEV1 according segment counting (2)
FEV1post-seg-2 = FEV1pre-op x [(19 - a - b)/(19 - a)], where a is the number of non-obstructed segments to be excised and b is the number of obstructed segments to be excised
Measured: Baseline (day 0)
Forced expiratory volume in 1 second (FEV1) from spirometry
Measured: Baseline (day 0)
Forced vital capacity from spirometry
Measured: Baseline (day 0)
Forced vital capacity from spirometry
Measured: 6 months
FEV1/FVC from spirometry
Measured: Baseline (day 0)
FEV1/FVC from spirometry
Measured: 6 months
Total lung capacity from spirometry
lung volumes
Measured: Baseline (day 0)
Total lung capacity from spirometry
lung volumes
Measured: 6 months
Residual lung volume from spirometry
lung volumes
Measured: Baseline (day 0)
Residual lung volume from spirometry
lung volumes
Measured: 6 months
Functional residual lung capacity from spirometry
lung volumes
Measured: Baseline (day 0)
Functional residual lung capacity from spirometry
lung volumes
Measured: 6 months
Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
Measured: Baseline (day 0)
Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
Measured: 6 months
Maximum volume of oxygen utilized per unit time (VO2Max)
Measured: Baseline (day 0)
Maximum volume of oxygen utilized per unit time (VO2Max)
Measured: 6 months
EQ-5D-5L questionnaire
The 5 level EQ-5D version (EQ-5D-5L) is a standardized instrument for measuring generic health status. It results in a single index score describing a general health profile ranging from 0 to 1, as well as a visual analogue scale.
Measured: Baseline (day 0)
EQ-5D-5L questionnaire
The 5 level EQ-5D version (EQ-5D-5L) is a standardized instrument for measuring generic health status. It results in a single index score describing a general health profile ranging from 0 to 1, as well as a visual analogue scale.
Measured: 6 months
QLQ-C30 Version 3.0 questionnaire
The QLQ-C30 Version 3.0 (a quality of life questionnaire for lung cancer patients) results in three scale scores [(i) level of function, (ii) global health status, and (iii) symptomatology / problems] with higher scores (ranging from 0 to 100) representing a higher response level.
Measured: Baseline (day 0)
QLQ-C30 Version 3.0 questionnaire
The QLQ-C30 Version 3.0 (a quality of life questionnaire for lung cancer patients) results in three scale scores [(i) level of function, (ii) global health status, and (iii) symptomatology / problems] with higher scores (ranging from 0 to 100) representing a higher response level.
Measured: 6 months
QLQ-LC13 questionnaire
The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.
Measured: Baseline (day 0)
QLQ-LC13 questionnaire
The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.
Measured: 6 months
Number of participants with complications
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start21 Sep 2020
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Bommart, MD, Study director, University Hospitals of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885765
- Sponsor's protocol ID
- RECHMPL17_0370
- Acronym
- CLIPPCAIR
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2019
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).
Publications
Suehs CM, Solovei L, Hireche K, Vachier I, Mariano Goulart D, Gamon L, Charriot J, Serre I, Molinari N, Bourdin A, Bommart S. Complication and lung function impairment prediction using perfusion and computed tomography air trapping (CLIPPCAIR): protocol for the development and validation of a novel multivariable model for the prediction of post-resection lung function. Ann Transl Med. 2021 Jul;9(13):1092. doi: 10.21037/atm-21-214.
PubMed 34423004
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR): Protocol for the Development and Validation of a Novel Algorithm for Post-resection Lung Function
- ClinicalTrials.gov ID
- NCT03885765
- Acronym / sponsor ID
- CLIPPCAIR / RECHMPL17_0370
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 22 Mar 2019 (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 primary objective of the CLIPPCAIR study is to construct and validate a new algorithm for predicting post-operative forced expiratory volume in 1 second (FEV1) values for lung resection candidates; this new model will be based on data derived from a thoracic CT scan with injection of contrast media.
Detailed description
Secondarily, the predictions made using traditional scintigraphic data will be compared with those from the new algorithm in a subset of high-risk patients, and cumulative contrast media and irradiation doses associated with imaging will be presented. How other measures of pulmonary function (e.g. transfer factor of the lung for carbon monoxide (TLCO)) and the presence/absence of operative complications might be predicted will also be investigated. Additionally, the potential links between (i) pre-surgical imaging data, (ii) post-surgical changes in respiratory function, and (iii) changes in health related quality of life will also be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Diagnostic Test: Predictive data, Procedure: Lung resectionThe first 60 patients recruited. |
| Validation group | – | Diagnostic Test: Predictive data, Procedure: Lung resectionThe last 100 patients recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The targeted study population corresponds to non-small cell lung cancer patients requiring pulmonary excision and who need to update their computed tomography scan data (CT scan) prior to surgery.
Key inclusion criteria (5 listed)
- Patient diagnosed with non-small cell lung cancer
- Indication for pulmonary excision surgery
- Patient requiring a more recent pre-surgical computed tomography scan (CT scan)
- The patient has been correctly informed about the study and has signed the consent form
- The patient is affiliated with or a beneficiary of the French single-payer social security programme (national health insurance)
Key exclusion criteria (5 listed)
- Patient in an exclusion period determined by another protocol
- Participation in another study that may affect the results of the present study (anti-cancer treatment studies are allowed)
- Patient under legal or judicial protection
- Contraindication to surgery or iodine injection
- Pregnant or lactating women
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 |
|---|---|---|
| Predictive dataThe novel predictive data in this study includes 5 predefined variables derived from thoracic CT scans: (i) Expiratory to inspiratory ratio of mean lung density (MLDe/i), total; (ii) MLDe/i of the section to be excised / MLDe/i total; (iii) Percentage of emphysema according to voxel thresholding at -950 HU (PVOX-950), total; (iv) PVOX-950 for the section to be excised; (v) Iodine concentration [I] of the section to be excised / [I] total. | Diagnostic test | Test group, Validation group |
| Lung resectionSurgical resection will be characterised by type (pneumonectomy, bi-lobectomy, lobectomy, or lobectomy with anastomosis resection), whether or not lymph node dissection was performed, and whether or not the resection was atypical. | Procedure or surgery | Test group, Validation group |
Primary outcome
Forced expiratory volume in 1 second (FEV1) from spirometry
Time frame: 6 months
Correlation between predicted and real values for post-surgical FEV1
Time frame: 6 months
26 secondary outcomes
Estimated post-operative FEV1 (litres) according to scintigraphy
Time frame: Baseline (day 0)
Estimated post-operative TLCO according to scintigraphy
Time frame: Baseline (day 0)
Estimated post-operative FEV1 according segment counting (1)
Time frame: Baseline (day 0)
Estimated post-operative FEV1 according segment counting (2)
Time frame: Baseline (day 0)
Forced expiratory volume in 1 second (FEV1) from spirometry
Time frame: Baseline (day 0)
Forced vital capacity from spirometry
Time frame: Baseline (day 0)
Forced vital capacity from spirometry
Time frame: 6 months
FEV1/FVC from spirometry
Time frame: Baseline (day 0)
FEV1/FVC from spirometry
Time frame: 6 months
Total lung capacity from spirometry
Time frame: Baseline (day 0)
Total lung capacity from spirometry
Time frame: 6 months
Residual lung volume from spirometry
Time frame: Baseline (day 0)
Residual lung volume from spirometry
Time frame: 6 months
Functional residual lung capacity from spirometry
Time frame: Baseline (day 0)
Functional residual lung capacity from spirometry
Time frame: 6 months
Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
Time frame: Baseline (day 0)
Transfer factor of the lung for carbon monoxide (TLCO) from spirometry
Time frame: 6 months
Maximum volume of oxygen utilized per unit time (VO2Max)
Time frame: Baseline (day 0)
Maximum volume of oxygen utilized per unit time (VO2Max)
Time frame: 6 months
EQ-5D-5L questionnaire
Time frame: Baseline (day 0)
EQ-5D-5L questionnaire
Time frame: 6 months
QLQ-C30 Version 3.0 questionnaire
Time frame: Baseline (day 0)
QLQ-C30 Version 3.0 questionnaire
Time frame: 6 months
QLQ-LC13 questionnaire
Time frame: Baseline (day 0)
QLQ-LC13 questionnaire
Time frame: 6 months
Number of participants with complications
Time frame: 0 to 6 months
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 22 Jun 2025.
- Background: PubMed 34423004Suehs CM, Solovei L, Hireche K, Vachier I, Mariano Goulart D, Gamon L, Charriot J, Serre I, Molinari N, Bourdin A, Bommart S. Complication and lung function impairment prediction using perfusion and computed tomography air trapping (CLIPPCAIR): protocol for the development and validation of a novel multivariable model for the prediction of post-resection lung function. Ann Transl Med. 2021 Jul;9(13):1092. doi: 10.21037/atm-21-214.
- Individual participant dataSharing planned: Yes. The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).
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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.
Sébastien Bommart, MD study director
University Hospitals of Montpellier, France
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, Montpellier 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 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 22 Jun 2025. 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?
Forced expiratory volume in 1 second (FEV1) from spirometry (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03885765, 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 22 Jun 2025.