Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

N/AActive Not RecruitingNCT03299478

University Hospital of North Norway865 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

865

Conditions

Non-Small Cell Lung Cancer

Interventions

Will look for immune infiltrationOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Rigshospitalet

Copenhagen, København Ø, Denmark

Odense Universitetshospital

Odense, Denmark

Oslo University Hospital

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Overall survival

Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Time frame: 5 year follow-up

Secondary Outcomes

TTR

Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Time frame: 5 year follow-up

Disease-specific survival

Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Time frame: 5 year follow-up

Data from ClinicalTrials.gov

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