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Trial registered on ANZCTR


Registration number
ACTRN12618001024235
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
19/06/2018
Date last updated
19/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of dendritic cells (DCs) in non-small-cell lung carcinoma (NSCLC) patients receiving anti-PD-1 immunotherapy
Scientific title
The role of dendritic cells (DCs) in non-small-cell lung carcinoma (NSCLC) patients receiving anti-PD-1 immunotherapy
Secondary ID [1] 295189 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small-cell lung carcinoma 308301 0
Condition category
Condition code
Cancer 307306 307306 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with non-small-cell lung carcinoma who will be receiving anti-PD-1 immunotherapy as 1st or 2nd line therapy as standard of care will have serial blood samples taken at baseline and prior to each cycle for as long as they remain on therapy for up to 2 years or until death. Serum will be analysed for a panel of inflammatory cytokines. Participants will also be asked for access to archival tumour tissue samples for analysis using immunohistochemistry staining for dendritic cell sub-populations.
Intervention code [1] 301512 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306265 0
Expression levels of a panel of inflammatory cytokines (including interferons, tumour necrosis factors, T-regulatory cell cytokines and matrix metaloproteinases) in non-small-cell lung carcinoma patients receiving anti-PD-1 immunotherapy as assessed by a serum assay.
Timepoint [1] 306265 0
Baseline, 3 weekly (prior to each cycle of therapy) for as long as they remain on therapy for up to 2 years or until death.
Primary outcome [2] 306266 0
Expression levels of dendritic cell subtypes in the tumour microenvironemt of patients prior to receiving anti-PD-1 immunotherapy as assessed by immunohistochemistry .
Timepoint [2] 306266 0
Prior to commencement of immunotherapy.
Secondary outcome [1] 348020 0
Distribution of interferon lambda receptor in the tumour microenvironement of patients with non-small-cell lung carcinoma as assessed by immhunohistochemistry.
Timepoint [1] 348020 0
Prior to commencement of immunotherapy.
Secondary outcome [2] 348021 0
Distribution of PD-1 in the tumour microenvironment of patients with non-small-cell lung carcinoma as assessed by immunohistochemistry.
Timepoint [2] 348021 0
Prior to commencement of immunotherapy
Secondary outcome [3] 348214 0
Distribution of PD-1 ligand in the tumour microenvironment of patients with non-small-cell lung carcinoma as assessed by immunohistochemistry.
Timepoint [3] 348214 0
Prior to commencement of immunotherapy

Eligibility
Key inclusion criteria
Histologically confirmed NSCLC
Commencing anti-PD-1 immunotherapy as 1st or 2nd line therapy.
Eastern Cooperative Oncology Group (ECOG) perfomance score 0-2
Informed consent given for participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy less than 12 weeks

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/06/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11128 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 22944 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 299761 0
Hospital
Name [1] 299761 0
Monash Health Oncology Department
Country [1] 299761 0
Australia
Primary sponsor type
Hospital
Name
Monash Health Oncology Department
Address
246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 299106 0
None
Name [1] 299106 0
Address [1] 299106 0
Country [1] 299106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300652 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300652 0
246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 300652 0
Australia
Date submitted for ethics approval [1] 300652 0
18/04/2018
Approval date [1] 300652 0
15/05/2018
Ethics approval number [1] 300652 0
HREC/18/MonH/346

Summary
Brief summary
The purpose of this study is to determine if specific immune system cells, called dendritic cells, have a role in patients with non-small-cell lung carcinoma undergoing anti-PD-1 immunotherapy.

Who is it for?

You may be eligible for this study is you are an adult who has confirmed non-small-cell lung carcinoma.

Study details
Patients from Monash Medical Centre with non-small-cell lung carcinoma to be treated with anti-PD-1 immunotherapy who consent to this study, will have blood samples taken at baseline (before commencing therapy) and prior to each treatment cycle (approximately every 2 to 3 weeks). The blood and serum samples will then be used to test for inflammatory markers. Additionally, participants archival tissue samples will also be used to detect dendritic cells and expression of PD-1.

The identification of markers associated treatment response would allow for greater accuracy in selecting potential responders to treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84346 0
Dr Maja Green
Address 84346 0
Monash University
Level 7, Monash Health Translation Precinct
246 Clayton Road
Clayton | VIC 3165 | Australia
Country 84346 0
Australia
Phone 84346 0
+6145248058
Fax 84346 0
Email 84346 0
[email protected]
Contact person for public queries
Name 84347 0
Maja Green
Address 84347 0
Monash University
Level 7, Monash Health Translation Precinct
246 Clayton Road
Clayton | VIC 3165 | Australia
Country 84347 0
Australia
Phone 84347 0
+61045248058
Fax 84347 0
Email 84347 0
[email protected]
Contact person for scientific queries
Name 84348 0
Maja Green
Address 84348 0
Monash University
Level 7, Monash Health Translation Precinct
246 Clayton Road
Clayton | VIC 3165 | Australia
Country 84348 0
Australia
Phone 84348 0
+61045248058
Fax 84348 0
Email 84348 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.