Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000090910
Ethics application status
Approved
Date submitted
10/07/2019
Date registered
3/02/2020
Date last updated
20/01/2022
Date data sharing statement initially provided
3/02/2020
Date results information initially provided
20/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can biomarkers be used to improve patient selection and overall survival in patients starting immunotherapy treatment for non-small cell lung cancer (NSCLC) and genitourinary cancers
Scientific title
Development of less-invasive predictive biomarkers of immunotherapy treatment in patients with non-small cell lung (NSCLC) and genitourinary cancers and its impact on overall survival
Secondary ID [1] 298699 0
None
Universal Trial Number (UTN)
U1111-1236-7893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 313600 0
Bladder cancer 313601 0
Kidney Cancer 313602 0
Condition category
Condition code
Cancer 312037 312037 0 0
Lung - Non small cell
Cancer 312038 312038 0 0
Bladder
Cancer 312039 312039 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants with advanced non-small cell lung, bladder and kidney cancers who are newly commencing immunotherapy treatment will be recruited. Participants will provide blood samples at regular intervals (baseline, 3 weeks, 6 weeks, 3 months, 6 months and 12 months) and urine/stool samples (baseline, 6 weeks, 6 months)
Intervention code [1] 314965 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320671 0
Overall survival - data-linkage to medical records
Timepoint [1] 320671 0
12 months after starting immunotherapy
Primary outcome [2] 320672 0
Progression Free Survival - data linkage to medical records
Timepoint [2] 320672 0
12 months after starting immunotherapy
Primary outcome [3] 320673 0
Response Rate - data linkage to medical records, progress CT scan
Timepoint [3] 320673 0
3 months after starting immunotherapy
Secondary outcome [1] 372448 0
Adverse events (rash, enterocolitis, hyperthyroidism, hypothyroidism, hepatitis) - these will be evaluated by clinical examination, participant self-reported and data linkage to medical records
Timepoint [1] 372448 0
3 months, 6 months, 9 months and 12 months after starting immunotherapy

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed non-small cell lung cancer, bladder cancer, kidney cancer
Must be commencing immunotherapy for NSCLC, renal or bladder cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not commencing immunotherapy
No consent signed

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Univariate and multivariate cox regression will be used to analyse progression free survival (PFS) and overall survival (OS).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/07/2019
Date of last participant enrolment
Anticipated
25/12/2020
Actual
25/12/2020
Date of last data collection
Anticipated
25/12/2021
Actual
25/11/2021
Sample size
Target
70
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14178 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 14179 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 27158 0
2170 - Liverpool
Recruitment postcode(s) [2] 27159 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 303211 0
Hospital
Name [1] 303211 0
Liverpool Hospital Medical Oncology Clinical Trials and Staff Specialist Trust Funds
Country [1] 303211 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Ingham Institute for Applied Medical Research
Address
1 Campbell Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 303223 0
University
Name [1] 303223 0
Western Sydney University
Address [1] 303223 0
Corner of Narellan Road and Gilchrist Drive
Campbelltown NSW 2560
Country [1] 303223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303768 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303768 0
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 303768 0
Australia
Date submitted for ethics approval [1] 303768 0
08/04/2019
Approval date [1] 303768 0
13/06/2019
Ethics approval number [1] 303768 0
2019/ETH09770

Summary
Brief summary
This study aims to evaluate biomarkers from blood, tissue, urine, and stool, in order to assess how useful they are in predicting treatment response and side effects from Immunotherapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with non-small cell lung cancer, bladder cancer, or kidney cancer, for which you will be commencing Immunotherapy.

Study details
This study will involve a taking a variety of biological samples including, blood, urine, stool and tissue on seven separate occasions throughout the 12 month study period. The samples will be used to evaluate new tests (biomarkers) to assess how useful they are in predicting cancer outcomes.

It is hoped that these biomarker tests can provide insight to changes in tumour tissue, blood, stool and urine during treatment. The information from this study will be crucial in personalizing Immunotherapy treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94730 0
Dr Tamiem Adam
Address 94730 0
Liverpool Cancer Therapy Centre, Liverpool Hospital
1 Campbell Street
Liverpool NSW 2170
Country 94730 0
Australia
Phone 94730 0
+61 2 8738 9000
Fax 94730 0
Email 94730 0
[email protected]
Contact person for public queries
Name 94731 0
Dr Tamiem Adam
Address 94731 0
Liverpool Cancer Therapy Centre, Liverpool Hospital
1 Campbell Street
Liverpool NSW 2170
Country 94731 0
Australia
Phone 94731 0
+61 2 8738 9000
Fax 94731 0
Email 94731 0
[email protected]
Contact person for scientific queries
Name 94732 0
Dr Tamiem Adam
Address 94732 0
Liverpool Cancer Therapy Centre, Liverpool Hospital
1 Campbell Street
Liverpool NSW 2170
Country 94732 0
Australia
Phone 94732 0
+61 2 8738 9000
Fax 94732 0
Email 94732 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.