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Trial registered on ANZCTR


Registration number
ACTRN12622000791730
Ethics application status
Approved
Date submitted
19/04/2022
Date registered
3/06/2022
Date last updated
17/04/2024
Date data sharing statement initially provided
3/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating lung cancer biomarkers in patients with non-small cell lung cancer.
Scientific title
Assessing the effect of post-radiotherapy circulating tumour cell levels on survival and disease progression in patients with non-small cell lung cancer.
Secondary ID [1] 306960 0
None
Universal Trial Number (UTN)
Trial acronym
LCB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 326076 0
Condition category
Condition code
Cancer 323387 323387 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
Standard Radiation Therapy with Curative intent, Blood collection for biomarker analysis.

Blood samples will be collected prior to radiotherapy treatment, up to 3 pre-defined intervals during treatment (24 hours after commencement of radiotherapy, mid point of radiotherapy and final week of radiotherapy) and a sample at 6-8 weeks post radiotherapy treatment which will coincide with response assessment imaging. A further sample will be taken at the time of suspected relapse, should this occur. Blood samples will be collected on days you are already visiting the hospital.

Follow up for overall survival, freedom from metastasis, freedom from disease progression, and thromboembolic events will continue until the last trial participant completes 1 years follow-up. This is routine care and the information will be collected from your medical record with no further involvement required.
Intervention code [1] 323405 0
Early Detection / Screening
Intervention code [2] 323628 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331123 0
To discover if any of the CTC parameters to be measured in this study, including CTC number, the presence of CTC clusters or EMT morphology are associated with freedom from distant metastasis, local failure or overall survival.
All associations will be assessed as a composite primary outcome.
Timepoint [1] 331123 0
Assessed at pre-defined intervals through blood samples and medical record review. Blood samples collected at the following timepoints: pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment. A further sample will be taken at the time of suspected relapse, should this occur.
Primary outcome [2] 331435 0
To discover if baseline levels or changes in ctDNA or exosomes are associated with freedom from distant metastasis, local failure or overall survival.
All associations will be assessed as a composite primary outcome.
Timepoint [2] 331435 0
Assessed at pre-defined intervals through blood samples and medical record review. Blood samples collected at the following timepoints: pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment. A further sample will be taken at the time of suspected relapse, should this occur.
Primary outcome [3] 331436 0
To discover if expression of genes associated with epithelial to mesenchymal transition (EMT) in CTCs detected before, during or after Radiation Therapy (RT) are associated with freedom from distant metastasis, local failure or overall survival.
All associations will be assessed as a composite primary outcome.
Timepoint [3] 331436 0
Assessed at pre-defined intervals through blood samples and medical record review. Blood samples collected at the following timepoints: pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment. A further sample will be taken at the time of suspected relapse, should this occur.
Secondary outcome [1] 408848 0
Mobilisation of Circulating Tumour Cells (CTC) by treatment, Blood samples collected at the following timepoints: pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment. A further sample will be taken at the time of suspected relapse, should this occur.
Timepoint [1] 408848 0
Analysis of bio specimens at pre-defined intervals. Blood samples collected at the following timepoints: pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment. A further sample will be taken at the time of suspected relapse, should this occur.
Secondary outcome [2] 409102 0
Analyses of circulating tumour DNA and exosomes from blood samples. Clearance of ctDNA or tumour related exosomal changes.
Timepoint [2] 409102 0
Analysis of bio specimens at pre-defined intervals throughout radiation therapy (pre-radiotherapy treatment, 24 hours after commencement of radiotherapy, midpoint of radiotherapy, final week of radiotherapy and at time of disease assessment). A further sample will be taken at the time of suspected relapse, should this occur.
Secondary outcome [3] 409103 0
Thromboembolic events in relation to CTCs and baseline clotting factors through blood samples and medical record review.

Timepoint [3] 409103 0
Participants will be followed up in 3 monthly intervals from completion of radiotherapy (or more often if required clinically) until last patient enrolled completes one year follow up.

Eligibility
Key inclusion criteria
Patients eligible for curative Radiation Therapy for Non-Small Cell Lung Cancer after PET staging
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Low Tumour burden (Largest Tumour <2cm in diameter). Women who are pregnant or lactating.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/12/2016
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
100
Accrual to date
82
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311277 0
Government body
Name [1] 311277 0
NHMRC
Country [1] 311277 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Clinical Research Development and Operations (CRDO), 305 Grattan St, Melbourne 3000 VIC
Country
Australia
Secondary sponsor category [1] 312637 0
None
Name [1] 312637 0
Address [1] 312637 0
Country [1] 312637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310784 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 310784 0
305 Grattan Street
Melbourne 3000 VIC
Ethics committee country [1] 310784 0
Australia
Date submitted for ethics approval [1] 310784 0
Approval date [1] 310784 0
25/08/2016
Ethics approval number [1] 310784 0

Summary
Brief summary
This is an observational study which aims to see if levels of circulating tumour cells (CTCs) mobilised during curative-intent radiotherapy (RT) for non-small cell lung cancer (NSCLC) can be used to predict disease progression and development of metastases.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and you have been deemed eligible to receive RT for NSCLC after positron emission tomography (PET) staging.

Study details
All participants will have collection of blood samples to measure the level of CTCs, pre-treatment, up to 3 pre-defined intervals (24 hours after commencement of radiotherapy, midway through radiotherapy, and final week of radiotherapy) throughout treatment and at disease assessment. A further sample will be taken at the time of suspected relapse, should this occur. These samples are collected on days participants are already attending the hospital. This will then be analysed to determine the correlation with survival, metastasis, local disease progression, and thromboembolic events (i.e. the development of blood clots) as determined by a review of medical records. The DNA of CTC samples will also be assessed to determine whether this influences any of the above parameters.

Participants will be followed up in clinic as per standard of care requirements at 3 monthly intervals from completion of radiotherapy (or more often if required clinically) until last patient enrolled completes one year follow up.

It is hoped that this study may show whether changes in CTC or CTC DNA levels after radiotherapy may have prognostic significance. Although this will not influence your current treatment, this may be used to inform the treatment of patients with NSCLC in future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118850 0
Prof Michael MacManus
Address 118850 0
Department Radiation Oncology
305 Grattan St
Melbourne 3000 VIC
Country 118850 0
Australia
Phone 118850 0
+61 3 8559 7761
Fax 118850 0
Email 118850 0
[email protected]
Contact person for public queries
Name 118851 0
Michael MacManus
Address 118851 0
Department Radiation Oncology
305 Grattan St
Melbourne 3000 VIC
Country 118851 0
Australia
Phone 118851 0
+61 3 8559 7761
Fax 118851 0
Email 118851 0
[email protected]
Contact person for scientific queries
Name 118852 0
Michael MacManus
Address 118852 0
Department Radiation Oncology
305 Grattan St
Melbourne 3000 VIC
Country 118852 0
Australia
Phone 118852 0
+61 3 8559 7761
Fax 118852 0
Email 118852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.