Clinical trial NCT03299478: Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
Official title: Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
name: Northern Health Authority
name: St. Olavs Hospital
name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Oslo University Hospital
name: University of Tromso
First posted: 2017-10-03
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pasients coming for resection of primary NSCLC with a curative intent

Brief summary: The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.

Detailed description: The main aim is to validate the most promising T-cell marker candidates from earlier studies in a prospective multicenter study to establish a prognostic TNM-Immunoscore.

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

Eligibility criteria: Inclusion Criteria:

* resectable NSCLC
* Age 18 and above
* no other malignancy last 5 years
* informed consent

Exclusion Criteria:

* multiple tumor foci
* preoperative chemo- or radiotherapy
* non-NSCLC histology
* no tissue available for study
* metastasis

Primary outcomes:
measure: Overall survival
timeFrame: 5 year follow-up
Secondary outcomes:
measure: TTR
timeFrame: 5 year follow-up
measure: Disease-specific survival
timeFrame: 5 year follow-up
Other outcomes:
Locations:
city: København
country: Denmark
facility: Rigshospitalet
state: København Ø
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St.Olav Hospital, University Hospital of Trondheim
Study officials:
affiliation: University Hospital of North Norway
name: Lill-Tove R Busund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Sigve Andersen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Tom Dønnem, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.