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Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR)

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ClinicalTrials.gov Identifier: NCT03885765
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Diagnostic Test: Predictive data Procedure: Lung resection

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : July 13, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Test group
The first 60 patients recruited.
Diagnostic Test: Predictive data

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.


Procedure: Lung resection
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.

Validation group
The last 100 patients recruited.
Diagnostic Test: Predictive data

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.


Procedure: Lung resection
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.




Primary Outcome Measures :
  1. Forced expiratory volume in 1 second (FEV1) from spirometry [ Time Frame: 6 months ]
  2. Correlation between predicted and real values for post-surgical FEV1 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Estimated post-operative FEV1 (litres) according to scintigraphy [ Time Frame: Baseline (day 0) ]
    Estimated post-operative FEV1 (litres) deduced from the regional FEV1 distribution according to lung scintigraphy

  2. Estimated post-operative TLCO according to scintigraphy [ Time Frame: Baseline (day 0) ]
    estimated post-operative Transfer factor of the lung for carbon monoxide (TLCO) deduced from the regional TLCO distribution

  3. Estimated post-operative FEV1 according segment counting (1) [ Time Frame: Baseline (day 0) ]
    FEV1post-seg-1 = FEV1pre-op x (1 - 0.0526 x N), where N is the number of segments to be excised

  4. Estimated post-operative FEV1 according segment counting (2) [ Time Frame: Baseline (day 0) ]
    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

  5. Forced expiratory volume in 1 second (FEV1) from spirometry [ Time Frame: Baseline (day 0) ]
  6. Forced vital capacity from spirometry [ Time Frame: Baseline (day 0) ]
  7. Forced vital capacity from spirometry [ Time Frame: 6 months ]
  8. FEV1/FVC from spirometry [ Time Frame: Baseline (day 0) ]
  9. FEV1/FVC from spirometry [ Time Frame: 6 months ]
  10. Total lung capacity from spirometry [ Time Frame: Baseline (day 0) ]
    lung volumes

  11. Total lung capacity from spirometry [ Time Frame: 6 months ]
    lung volumes

  12. Residual lung volume from spirometry [ Time Frame: Baseline (day 0) ]
    lung volumes

  13. Residual lung volume from spirometry [ Time Frame: 6 months ]
    lung volumes

  14. Functional residual lung capacity from spirometry [ Time Frame: Baseline (day 0) ]
    lung volumes

  15. Functional residual lung capacity from spirometry [ Time Frame: 6 months ]
    lung volumes

  16. Transfer factor of the lung for carbon monoxide (TLCO) from spirometry [ Time Frame: Baseline (day 0) ]
  17. Transfer factor of the lung for carbon monoxide (TLCO) from spirometry [ Time Frame: 6 months ]
  18. Maximum volume of oxygen utilized per unit time (VO2Max) [ Time Frame: Baseline (day 0) ]
  19. Maximum volume of oxygen utilized per unit time (VO2Max) [ Time Frame: 6 months ]
  20. EQ-5D-5L questionnaire [ Time Frame: Baseline (day 0) ]
    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.

  21. EQ-5D-5L questionnaire [ Time Frame: 6 months ]
    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.

  22. QLQ-C30 Version 3.0 questionnaire [ Time Frame: Baseline (day 0) ]
    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.

  23. QLQ-C30 Version 3.0 questionnaire [ Time Frame: 6 months ]
    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.

  24. QLQ-LC13 questionnaire [ Time Frame: Baseline (day 0) ]
    The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.

  25. QLQ-LC13 questionnaire [ Time Frame: 6 months ]
    The QLQ-LC13 provide an additional lung-cancer-specific symptom scale ranging from 0 to 100 with higher scores indicating worse symptomatology.

  26. Number of participants with complications [ Time Frame: 0 to 6 months ]

Biospecimen Retention:   Samples Without DNA

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patient in an exclusion period determined by another protocol
  • Participation in another study that may affect the results of the present study
  • Patient under legal or judicial protection
  • Contraindication to surgery or iodine injection
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885765


Contacts
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Contact: Sébastien Bommart, MD, PhD +33 (0)4.67.33.60.00 s-bommart@chu-montpellier.fr

Locations
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France
Arnaud de Villeneuve Hospital
Montpellier, France, 34295
Principal Investigator: Sébastien Bommart, MD, PhD         
Sub-Investigator: Arnaud Bourdin, MD, PhD         
Sub-Investigator: Maurice Hayot, MD, PhD         
Sub-Investigator: Jérémy Charriot, MD         
Sub-Investigator: Charles Marty Ane, MD, PhD         
Sub-Investigator: Kheira Hireche, MD         
Sub-Investigator: Laurence Solovei, MD         
Sub-Investigator: Fares Gouzi, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Sébastien Bommart, MD University Hospitals of Montpellier, France
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03885765    
Other Study ID Numbers: RECHMPL17_0370
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 the public on a not-for-profit, free platform that allows access control (zenodo.org). Links on osf.io will point towards the upload.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame:

Individual datasets (with final report and analytic code) will be made available to reviewers at time of submission. Full public access to data will be implemented within 4 weeks following the final publication acceptation.

Supporting documents will preferentially be published (eg the protocol with SAP), or otherwise posted at the URL below.

Access Criteria:

The conditions under which members of the public will be granted access (via zenodo.org) to the uploaded data files and associated documents are:

  • The data will be used/examined in a not-for-profit manner;
  • The data will not be used in an attempt to identify a participant or group of participants;
  • The user does not work for a private insurance company;
  • The data will not be used in support of any kind of private insurance policy or health penalties;
  • The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;
  • The user will state why they wish to access the data.
URL: https://osf.io/2m7z4/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases