NCT03299478

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Nov 2016Feb 2027

Study Start

First participant enrolled

November 28, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 11, 2024

Status Verified

May 1, 2024

Enrollment Period

10.2 years

First QC Date

September 27, 2017

Last Update Submit

June 10, 2024

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    5 year follow-up

Secondary Outcomes (2)

  • TTR

    5 year follow-up

  • Disease-specific survival

    5 year follow-up

Study Arms (1)

NSCLC patients

Resected NSCLC patients with curative intent

Other: Will look for immune infiltration

Interventions

Will look for immune infiltrationOTHER
NSCLC patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pasients coming for resection of primary NSCLC with a curative intent

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Oslo University Hospital

Oslo, 0379, Norway

Location

University Hospital of North Norway

Tromsø, 9038, Norway

Location

St.Olav Hospital, University Hospital of Trondheim

Trondheim, 7006, Norway

Location

Related Publications (2)

  • 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.

    PMID: 26578726BACKGROUND

  • 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.

    PMID: 37100205RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tumor specimen Blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lill-Tove R Busund, MD, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

  • Sigve Andersen, MD,PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

  • Tom Dønnem, MD,PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 3, 2017

Study Start

November 28, 2016

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 11, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)DK(2)