An observational study in Non-small Cell Lung Cancer, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 160 is close to the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The first 60 patients recruited.
Diagnostic Test: Predictive data · Procedure: Lung resection
The last 100 patients recruited.
Diagnostic Test: Predictive data · Procedure: Lung resection
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.
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.
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
Estimated post-operative FEV1 (litres) according to scintigraphy
Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy
Time frame: 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
Time frame: 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
Time frame: 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
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
lung volumes
Time frame: Baseline (day 0)
Total lung capacity from spirometry
lung volumes
Time frame: 6 months
Residual lung volume from spirometry
lung volumes
Time frame: Baseline (day 0)
Residual lung volume from spirometry
lung volumes
Time frame: 6 months
Functional residual lung capacity from spirometry
lung volumes
Time frame: Baseline (day 0)
Functional residual lung capacity from spirometry
lung volumes
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Number of participants with complications
Time frame: 0 to 6 months
Plan to share: 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).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
University Hospital, Montpellier