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Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization (K-FPI)

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ClinicalTrials.gov Identifier: NCT03486262
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.

Condition or disease
Lung Cancer and Idiopathic Pulmonary Fibrosis

Detailed Description:

Primary objective:

Characterize altered molecular pathways in lung cancer in patients with IPF versus lung cancer in non-IPF patients.

Secondary objectives:

Identify specific therapeutic targets Describe a cohort of lung cancers on IPF (clinical / radiological and pathological data) To study the relationship between neoplastic / preneoplastic lesions and pulmonary parenchyma reshaped by fibrosis.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Group/Cohort
Lung carcinoma on IPF
Lung carcinoma on IPF



Primary Outcome Measures :
  1. Molecular profile of IPF-associated lung carcinomas [ Time Frame: 1 month / 8 samples ]
    Next generation sequencing of carcinomas with Ion S5 XL sequencer and Oncomine™ Comprehensive Panel


Secondary Outcome Measures :
  1. Pathological characterization of lung carcinomas [ Time Frame: 1 month / 8 samples ]
    Histological classification of carcinomas and immunohistochemistry with lineage markers


Biospecimen Retention:   Samples Without DNA
Formalin fixed paraffin embedded lung samples


Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.
Criteria

Inclusion Criteria:

  • Lung carcinoma
  • Idiopathic pulmonary fibrosis

Exclusion Criteria:

- No tumor sample available


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): NCT03486262


Locations
France
Hopital BICHAT-CLAUDE BERNARD
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Auréie CAZES, MD PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03486262     History of Changes
Other Study ID Numbers: NI16034
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lung cancer; Idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Neoplasms
Fibrosis
Pulmonary Fibrosis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases, Interstitial