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NCT Number: NCT03299478

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, København Ø, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Will look for immune infiltration

Other

Primary outcomes

  1. Overall survival

    Time frame: 5 year follow-up

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

Secondary outcomes

  1. TTR

    Time frame: 5 year follow-up

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

  2. Disease-specific survival

    Time frame: 5 year follow-up

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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Northern Health Authority
  • Norwegian Cancer Society
  • Odense University Hospital
  • Oslo University Hospital
  • Rigshospitalet, Denmark
  • St. Olavs Hospital
  • University of Tromso

Registry information

Acronym: TNM-I

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2017
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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