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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | The first 60 patients recruited. |
| |
| Validation group | The last 100 patients recruited. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predictive data | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) from spirometry | 6 months | |
| Correlation between predicted and real values for post-surgical FEV1 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated post-operative FEV1 (litres) according to scintigraphy | Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy | Baseline (day 0) |
| Estimated post-operative TLCO according to scintigraphy |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Bommart, MD | University Hospitals of Montpellier, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34423004 | Background | 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. |
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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).
Datasets can be requested after the publication process has been completed.
The conditions under which members of the public will be granted access to datasets are:
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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40 resected lung tissues for the routine pathological analysis may be retained for ancillary studies if the investigator :
These lung tissues can't be retained if :
|
| Lung resection | Procedure | 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. |
|
estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution |
| 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 | 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 | Baseline (day 0) |
| Forced expiratory volume in 1 second (FEV1) from spirometry | Baseline (day 0) |
| Forced vital capacity from spirometry | Baseline (day 0) |
| Forced vital capacity from spirometry | 6 months |
| FEV1/FVC from spirometry | Baseline (day 0) |
| FEV1/FVC from spirometry | 6 months |
| Total lung capacity from spirometry | lung volumes | Baseline (day 0) |
| Total lung capacity from spirometry | lung volumes | 6 months |
| Residual lung volume from spirometry | lung volumes | Baseline (day 0) |
| Residual lung volume from spirometry | lung volumes | 6 months |
| Functional residual lung capacity from spirometry | lung volumes | Baseline (day 0) |
| Functional residual lung capacity from spirometry | lung volumes | 6 months |
| Transfer factor of the lung for carbon monoxide (TLCO) from spirometry | Baseline (day 0) |
| Transfer factor of the lung for carbon monoxide (TLCO) from spirometry | 6 months |
| Maximum volume of oxygen utilized per unit time (VO2Max) | Baseline (day 0) |
| Maximum volume of oxygen utilized per unit time (VO2Max) | 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. | 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. | 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. | 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. | 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. | 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. | 6 months |
| Number of participants with complications | 0 to 6 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |