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Trial record 1 of 2 for:    KBP-2020-CPHG
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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 (KBP-2020-CPHG)

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ClinicalTrials.gov Identifier: NCT04402099
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Collège des Pneumologues des Hôpitaux Généraux

Brief 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.

Primary endpoint:

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

Condition or disease
Lung Cancer

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Estimate 1-year mortality rates in patients with PLC. [ Time Frame: 1 year ]
    Global survival at 1 year

  2. Estimate 5-year mortality rates in patients with PLC. [ Time Frame: 5 years ]
    Global survival at 5 years


Secondary Outcome Measures :
  1. Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020 [ Time Frame: 1 year ]
    - Patient data: age, gender, birth location, height, weight, comorbidity score, smoking status, cannabis uptake, Performance Status, and death

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Primary Lung Cancer histologically proven between January 1st and December 31st, 2020
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT04402099


Locations
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France
Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College) Recruiting
Paris, France, 75006
Contact: Didier Debieuvre, MD    +33 (0)3 89 64 73 96    debieuvred@ghrmsa.fr   
Sponsors and Collaborators
Collège des Pneumologues des Hôpitaux Généraux
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Responsible Party: Collège des Pneumologues des Hôpitaux Généraux
ClinicalTrials.gov Identifier: NCT04402099    
Other Study ID Numbers: 2019-A00943-54
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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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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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases