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Active, not recruitingNCT03299478TNM-IUpdated Jun 11, 2024

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

An observational study in Non-Small Cell Lung Cancer, sponsored by University Hospital of North Norway. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University Hospital of North Norway · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
865
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Non-Small Cell Lung Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pasients coming for resection of primary NSCLC with a curative intent

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
865 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • NSCLC patients

    Resected NSCLC patients with curative intent

    Other: Will look for immune infiltration

Interventions

  • OtherWill look for immune infiltration
05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

06

Study locations

5 sites
  • Rigshospitalet
    København, København Ø 2100, Denmark
  • Odense Universitetshospital
    Odense, 5000, Denmark
  • Oslo University Hospital
    Oslo, 0379, Norway
  • University Hospital of North Norway
    Tromsø, 9038, Norway
  • St.Olav Hospital, University Hospital of Trondheim
    Trondheim, 7006, Norway
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References and documents

Publications

  • 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. PubMed 26578726 ↗
  • 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. PubMed 37100205 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03299478
Lead sponsor
University Hospital of North Norway
Collaborators
Norwegian Cancer Society, Northern Health Authority, St. Olavs Hospital, Rigshospitalet, Denmark, Odense University Hospital, Oslo University Hospital, University of Tromso
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Nov 28, 2016
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Jun 11, 2024

Study contacts

Lill-Tove R Busund, MD, PhD
principal investigator · University Hospital of North Norway
Sigve Andersen, MD,PhD
principal investigator · University Hospital of North Norway
Tom Dønnem, MD,PhD
principal investigator · University Hospital of North Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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