Lung Cancer and Idiopathic Pulmonary FibrosisK-FPINCT03486262
Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization
An observational study of Lung Cancer and Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer and Idiopathic Pulmonary Fibrosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Lung carcinoma
- Idiopathic pulmonary fibrosis
Who cannot join
- No tumor sample available
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Lung cancer; Idiopathic pulmonary fibrosis
- Medical subject headings
- Lung Neoplasms, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung carcinoma on IPF | Lung carcinoma on IPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile of IPF-associated lung carcinomas
Next generation sequencing of carcinomas with Ion S5 XL sequencer and Oncomine™ Comprehensive Panel
Measured: 1 month / 8 samples
Secondary outcomes (1)
Pathological characterization of lung carcinomas
Histological classification of carcinomas and immunohistochemistry with lineage markers
Measured: 1 month / 8 samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Feb 2018
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer and Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Auréie CAZES, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486262
- Sponsor's protocol ID
- NI16034
- Acronym
- K-FPI
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization
- ClinicalTrials.gov ID
- NCT03486262
- Acronym / sponsor ID
- K-FPI / NI16034
- Keywords
- Lung cancer; Idiopathic pulmonary fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung carcinoma on IPF | – | –Lung carcinoma on IPF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Lung carcinoma
- Idiopathic pulmonary fibrosis
Key exclusion criteria (1 listed)
- No tumor sample available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Pathological characterization of lung carcinomas
Time frame: 1 month / 8 samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Auréie CAZES, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profile of IPF-associated lung carcinomas (time frame: 1 month / 8 samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.