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

Non-Small Cell Lung Cancer Clinical Trial

— TNM-I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03299478
• Other study ID #: 2016/714
• Status: Active, not recruiting
• Start date: November 28, 2016
• Est. completion date: February 1, 2027

Study information

• Verified date: May 2024
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 865
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Other:
• Will look for immune infiltration

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København	København Ø
Denmark	Odense Universitetshospital	Odense
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	St.Olav Hospital, University Hospital of Trondheim	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital of North Norway	Northern Health Authority, Norwegian Cancer Society, Odense University Hospital, Oslo University Hospital, Rigshospitalet, Denmark, St. Olavs Hospital, University of Tromso

Countries where clinical trial is conducted

Denmark,  Norway, 

References & 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. — View Citation

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, Hell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TTR	Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.	5 year follow-up
Secondary	Disease-specific survival	Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.	5 year follow-up