Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
NCT ID: NCT03299478
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
865 participants
OBSERVATIONAL
2016-11-28
2027-02-01
Brief Summary
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Detailed Description
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The investigators will include around 1000 stage I-IIIA patients from various centers in Scandinavia. The investigators will also collect demographic and clinicopathological data, blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by immunohistochemistry for validation and by other methods for exploration of their impact on prognosis
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NSCLC patients
Resected NSCLC patients with curative intent
Will look for immune infiltration
Interventions
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Will look for immune infiltration
Eligibility Criteria
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Inclusion Criteria
* Age 18 and above
* no other malignancy last 5 years
* informed consent
Exclusion Criteria
* preoperative chemo- or radiotherapy
* non-NSCLC histology
* no tissue available for study
* metastasis
18 Years
ALL
No
Sponsors
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Norwegian Cancer Society
OTHER
Northern Health Authority
OTHER_GOV
St. Olavs Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Odense University Hospital
OTHER
Oslo University Hospital
OTHER
University of Tromso
OTHER
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Lill-Tove R Busund, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Sigve Andersen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Tom Dønnem, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Locations
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Rigshospitalet
Copenhagen, København Ø, Denmark
Odense Universitetshospital
Odense, , Denmark
Oslo University Hospital
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
St.Olav Hospital, University Hospital of Trondheim
Trondheim, , Norway
Countries
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References
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Donnem T, Kilvaer TK, Andersen S, Richardsen E, Paulsen EE, Hald SM, Al-Saad S, Brustugun OT, Helland A, Lund-Iversen M, Solberg S, Gronberg BH, Wahl SG, Helgeland L, Flotten O, Pohl M, Al-Shibli K, Sandanger TM, Pezzella F, Busund LT, Bremnes RM. Strategies for clinical implementation of TNM-Immunoscore in resected nonsmall-cell lung cancer. Ann Oncol. 2016 Feb;27(2):225-32. doi: 10.1093/annonc/mdv560. Epub 2015 Nov 16.
Rakaee M, Andersen S, Giannikou K, Paulsen EE, Kilvaer TK, Busund LR, Berg T, Richardsen E, Lombardi AP, Adib E, Pedersen MI, Tafavvoghi M, Wahl SGF, Petersen RH, Bondgaard AL, Yde CW, Baudet C, Licht P, Lund-Iversen M, Gronberg BH, Fjellbirkeland L, Helland A, Pohl M, Kwiatkowski DJ, Donnem T. Machine learning-based immune phenotypes correlate with STK11/KEAP1 co-mutations and prognosis in resectable NSCLC: a sub-study of the TNM-I trial. Ann Oncol. 2023 Jul;34(7):578-588. doi: 10.1016/j.annonc.2023.04.005. Epub 2023 Apr 24.
Other Identifiers
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2016/714
Identifier Type: -
Identifier Source: org_study_id
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