Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT02488850
• Date of registration: 26/06/2015
• Prospective Registration: No
• Primary sponsor: Erasmus Medical Center
• Public title: Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC HAMLET
• Scientific title: Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage Non-small Cell Lung Cancer HAMLET Study
• Date of first enrolment: December 2012
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02488850
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Joachim G Aerts, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Cytologically or histologically proven cT1-2aN0M0 NSCLC

- Patients = 18 years old

- Patients should be fit to undergo both treatments in accordance with institutional
protocols

Exclusion Criteria:

- Patients with any signs of any co-existing infectious disease or immunosuppressive
treatment (inhalation steroids are permitted)

- Mentally incapacitated subjects



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Procedure: Surgery

Radiation: SABR

Primary Outcome(s)

Number of IFN-gamma/ Granzyme B producing CD8 T cells [Time Frame: Week 6]

Number of IFN-gamma/ Granzyme B producing CD8 T cells [Time Frame: Week 2]

Number of IFN-gamma/ Granzyme B producing CD8 T cells [Time Frame: Baseline (week 0)]

Number of IFN-gamma/ Granzyme B producing CD8 T cells [Time Frame: Week 1]

Number of IFN-gamma/ Granzyme B producing CD8 T cells [Time Frame: Week 3]

Secondary Outcome(s)

CD4/CD8 ratio in peripheral blood [Time Frame: Baseline]

number of regulatory T cells [Time Frame: Baseline]

CD4/CD8 ratio in peripheral blood [Time Frame: Week 2]

number of regulatory T cells [Time Frame: Week 6]

Activation marker expression on T cells [Time Frame: Week 3]

Activation marker expression on T cells [Time Frame: Week 6]

Activation marker expression on T cells [Time Frame: Week 1]

number of regulatory T cells [Time Frame: Week 2]

number of regulatory T cells [Time Frame: Week 3]

CD4/CD8 ratio in peripheral blood [Time Frame: Week 3]

Activation marker expression on T cells [Time Frame: Baseline]

Activation marker expression on T cells [Time Frame: Week 2]

CD4/CD8 ratio in peripheral blood [Time Frame: Week 6]

number of regulatory T cells [Time Frame: Week 1]

CD4/CD8 ratio in peripheral blood [Time Frame: Week 1]

Secondary ID(s)

NL42081.078.12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors