Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

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.

Predictive data

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.

Lung resection

Sébastien Bommart, MD, PhD

Arnaud Bourdin, MD, PhD

Maurice Hayot, MD, PhD

Jérémy Charriot, MD

Charles Marty Ane, MD, PhD

Kheira Hireche, MD

Laurence Solovei, MD

Fares Gouzi, MD

Sébastien Bommart, MD

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.

40 resected lung tissues for the routine pathological analysis may be retained for ancillary studies if the investigator :

* deems that sample recovery is feasible
* judges the distance between the cancerous lesion and the region of interest, sufficiently large/distinct
* obtained the patient's consent for the use of his remaining excised tissue specifically for this ancillary study

These lung tissues can't be retained if :

* unavailability of tissue sample due to routine analysis requirements
* patient has atelectasis
* patient has pulmonary infection
* patient has a pulmonary lesion linked to the surgical intervention

Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping

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 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).

Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy

estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution

FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised

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

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.

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.

The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.

Spots Global Cancer Trial Database for predictive data