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Lung CancerKBP-2020-CPHGNCT04402099

Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

An observational study of Lung Cancer, run by Collège des Pneumologues des Hôpitaux Généraux at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
How many people
10,000 participants
Where
1 siteFrance
Study dates
1 Jan 2020to 1 Jan 2026
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
  • Adult, Older adult

Study population: Primary Lung Cancer histologically proven between January 1st and December 31st, 2020

Who may be able to join

  • Age ≥ 18 years
  • Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020*
  • Follow-up by a lung specialist at a General Hospital
  • Oral informed consent * date of collected sample

Who cannot join

  • Age < 18 years
  • Secondary lung cancer
  • Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery
  • Previous enrolment in the study
  • Freedom deprived patient following a legal or administrative decision
  • Patient unable to give his(her) consent

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)

    Paris, 75006

    Didier Debieuvre, MD, +33 (0)3 89 64 73 96, debieuvred@ghrmsa.fr

    Recruiting

Other trials in France

About this study

Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade.

Primary endpoint:

Read more

Estimate 1-year- and 5-year-mortality rates in patients with PLC.

Secondary endpoints:

  • Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020
  • Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies
  • Estimate prognostic factors
  • Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and KBP-2000-CPHG studies
  • Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG studies
Conditions
Lung Cancer
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate 1-year mortality rates in patients with PLC.

    Global survival at 1 year

    Measured: 1 year

  2. Estimate 5-year mortality rates in patients with PLC.

    Global survival at 5 years

    Measured: 5 years

Secondary outcomes (2)
  1. Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020

    • Patient data: age, gender, birth location, height, weight, comorbidity score, smoking status, cannabis uptake, Performance Status, and death

    Measured: 1 year

  2. Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies

    • Disease data: diagnostic method, anatomopathological classification, PDL-1 status, molecular biology test, tumor mutation burden, TNM classification, and stage (8th edition)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402099
Sponsor's protocol ID
2019-A00943-54
Acronym
KBP-2020-CPHG
Status last verified
Jun 2020
First submitted
27 Apr 2020
Last updated
5 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Debieuvre D, Falchero L, Molinier O, Couraud S, Cortot A, Meyer N, Asselain B, Auvray E, Templement-Grangerat D, Bizieux A, Tredaniel J, Schneider S, Auliac JB, Bylicki O, Letierce A, Morel H. Survival of Patients with Lung Adenocarcinoma Diagnosed in 2000, 2010, and 2020. NEJM Evid. 2025 Jul;4(7):EVIDoa2400443. doi: 10.1056/EVIDoa2400443. Epub 2025 Jun 24.

    PubMed 40552964

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Collège des Pneumologues des Hôpitaux Généraux 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 4 inclusion and 6 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 5 Jun 2020. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate 1-year mortality rates in patients with PLC. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04402099, which also lists 1 linked publication.

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 5 Jun 2020.

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