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

Active, not recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: Will look for immune infiltration

• Registration Number: NCT03299478
• Lead Sponsor: University Hospital of North Norway

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

Study Timeline

• Study Start: 2016-11-28
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 865

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSCLC patients	Will look for immune infiltration	Resected NSCLC patients with curative intent

Primary Outcome Measures

Name	Time	Method
Overall survival	5 year follow-up	Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Secondary Outcome Measures

Name	Time	Method
TTR	5 year follow-up	Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Disease-specific survival	5 year follow-up	Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Trial Locations

Locations (5)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Rigshospitalet; 🇩🇰 København, København Ø, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

St.Olav Hospital, University Hospital of Trondheim; 🇳🇴 Trondheim, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway