Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathologi... | NCT03486262

Studies
Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

NCT03486262

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Oct 11, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lung Cancer and Idiopathic Pulmonary Fibrosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Feb 2020Estimated

Completion Date

Feb 2020Estimated

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

Mar 27, 2018

First Posted Date

Apr 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Lung carcinoma on IPF		Lung carcinoma on IPF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Molecular profile of IPF-associated lung carcinomas	Next generation sequencing of carcinomas with Ion S5 XL sequencer and Oncomine™ Comprehensive Panel	1 month / 8 samples

Secondary Outcomes

Measure	Description	Time Frame
Pathological characterization of lung carcinomas	Histological classification of carcinomas and immunohistochemistry with lineage markers	1 month / 8 samples

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lung carcinoma
Idiopathic pulmonary fibrosis

Exclusion Criteria:

- No tumor sample available

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Auréie CAZES, MD PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital BICHAT-CLAUDE BERNARD		Paris		75018	France

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided