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K-RAS and EGFR in Lung Cancer (K-RAS_NSCLC)

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ClinicalTrials.gov Identifier: NCT03951233
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Brief Summary:
Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Condition or disease
Non Small Cell Lung Cancer

Detailed Description:
A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

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Study Type : Observational
Actual Enrollment : 424 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genotyping K-RAS and EGFR in Greek Non-small-cell Lung Cancer Patients: Incidence, Significance and Treatment Implications
Actual Study Start Date : March 2000
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
K-RAS and EGFR mutated
Wild type



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 9 months ]
  2. Overall survival [ Time Frame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 36 months ]

Biospecimen Retention:   Samples With DNA
Formalin- fixed paraffin- embedded tissue blocks.


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
Patients treated within HeCOG-affiliated centres from March 2000 through December 2012.
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed NSCLC
  • Signed and dated written informed consent
  • Age 18 years
  • Available cytological material

Exclusion Criteria: -


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): NCT03951233


Locations
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Greece
Oncology Unit, Metropolitan Hospital
Néo Fáliro, Athens, Greece, 18547
Sponsors and Collaborators
Hellenic Cooperative Oncology Group

Publications of Results:
Other Publications:
Mountzios G, Linardou H, S. A, editors. Epidemiology and incidence of EGFR mutation in Greek patients with advanced NSCLC. National Hellenic Oncology Meeting; 2016.

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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT03951233     History of Changes
Other Study ID Numbers: K-RAS_NSCLC
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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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
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms