Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000853640
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
8/08/2023
Date last updated
8/08/2023
Date data sharing statement initially provided
8/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring Predictive and Prognostic Biomarkers in People with Cancer.
Scientific title
Exploring Predictive and Prognostic Biomarkers in People with Cancer.
Secondary ID [1] 309988 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer
 330491 0
Condition category
Condition code
Cancer 327339 327339 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients enrolled in this study will undergo the collection of clinical data, archival and/or excess fresh tumour specimens, and blood samples. Excess fresh tissue is residual tissue that is collected as part of a routine, standard of care biopsy. There will be no additional biopsies that are for research purposes only.

Clinical data, including patient demographics, will be collected from the medical records.

Patients that consent to blood collection will undergo blood sampling throughout their systemic therapy. This study will collect an additional 10-20mls at the same time when standard of care bloods are collected at baseline (before starting systemic therapy), 1 month, 3 months, 6 months, and 12 months later.

Patients may also consent to additional blood collections at an interval of every 3 months, for a maximum of a 3-year follow-up period, after the initial 12-month study period.

It is anticipated that an additional 5 minutes will be required to complete this study sampling for each timepoint. This is in addition to the participants' scheduled appointment time.

All tumour specimens collected as part of this study will be stored on site at designated laboratories, with blood products stored frozen in a -70C designated laboratories. Once a sufficient cohort has been enrolled, selected molecular analyses will be conducted on each specimen, thus, allowing for batching of specimens. All analyses are exploratory.
Intervention code [1] 326415 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335228 0
Identification and characterisation of potential new predictive and prognostic biomarkers in cancers (e.g. genetic, epigenetic, and protein-based biomarkers) from cancer specimens. They will be assessed using DNA, RNA, protein, and other cellular assays (e.g. DNA sequencing, RNA sequencing, Quantitative PCR, ELISA assessments, proteomic analysis, special transcriptomics).
Timepoint [1] 335228 0
The biomarkers will be assessed as a composite primary outcome.

Cancer specimen collection includes tumour biopsy and patient blood sampling. Retrieval of archival tissue will occur only at Screening/Baseline.

The study period collection schedule for the cancer specimen includes Screening/Baseline (pre starting systemic therapy) and then 1 month, 3 months, 6 months, 9 months, and 12 months, after the commencement of systemic therapy. Tumour biopsy and blood sampling will only be sought at these time points, as part of routine treatment and follow-up.

The follow-up period will be opt-in and involves collection of blood samples every 3 months, for a maximum of a 3-year follow-up period. The follow-up period collection schedule includes 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 39 months, 42 months, 45 months, and 48 months, after the commencement of systemic treatment. Blood sampling will only be sought at these time points, as part of routine treatment and follow-up.
Primary outcome [2] 335231 0
Assess the prognostic value of biomarkers when related to clinical endpoints (i.e. progression-free survival, overall survival, and overall response rate), accounting for clinical factors collected from routine care (e.g. CT images, review of medical records).
Timepoint [2] 335231 0
This is a composite primary outcome.

Clinical data, including patient demographics and survival outcomes, will be collected from the review of the medical records.

The study period collection schedule for clinical data includes Screening/Baseline (pre starting systemic therapy) and then 1 month, 3 months, 6 months, 9 months, and 12 months, after the commencement of systemic therapy.

The follow-up period will be opt-in. The follow-up period collection schedule includes 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 39 months, 42 months, 45 months, and 48 months, after the commencement of systemic therapy.
Secondary outcome [1] 423558 0
Nil
Timepoint [1] 423558 0
Nil

Eligibility
Key inclusion criteria
Monash Health patients will be included in this study if they meet all of the following inclusion criteria:
1. Aged 18 years or older
2. Histological or cytological diagnosis of solid organ cancer
3. Able to be accessible for follow-up and data collection
4. Able to provide written, voluntary and informed consent
5. Able to undergo core needle biopsy of metastases (patients must have a lesion which is deemed medically safe to biopsy as part of routine standard of care)
6. Able to undergo collection of blood specimens during treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Monash Health patients will be excluded from this study if they meet any of the following exclusion criteria:
1. Unable to be accessible for follow-up and data collection
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A univariate analysis of biomarkers as well as known/potential clinical prognostic factors will be carried out with relapse or cancer death as the endpoint, as well as overall survival time. Clinical factors will include histological subtype, differentiation status, gender, age, ethnicity and smoking status.

Biomarkers and clinical factors will be further tested on multivariate analysis (such as toxicity profile of immune-related adverse events).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2023
Actual
Date of last participant enrolment
Anticipated
15/08/2028
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24999 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 25000 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 40657 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 40656 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 314167 0
Hospital
Name [1] 314167 0
Monash Health
Country [1] 314167 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 316083 0
None
Name [1] 316083 0
Address [1] 316083 0
Country [1] 316083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313295 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 313295 0
Research Support Services
Monash Health
Level 2, i Block
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 313295 0
Australia
Date submitted for ethics approval [1] 313295 0
22/11/2022
Approval date [1] 313295 0
24/05/2023
Ethics approval number [1] 313295 0
RES-22-0000-701A

Summary
Brief summary
This study aims to identify biological markers in tumour and blood samples which may predict clinical outcomes and responses to treatment for people with a variety of cancer types, including but not limited to melanoma, lung cancer, breast cancer, colorectal cancer and genitourinary cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid organ cancer, including but not limited to melanoma, lung cancer, breast cancer, colorectal/bowel cancer, cervical cancer, ovarian cancer, or liver cancer.

Study details
All participants who choose to enrol in this study will be asked to consent to having their health information (collected as part of their diagnosis and treatment) accessed by the research team.

Participants who have already had tumour samples taken will be asked to consent to having some of these samples used for additional testing to determine if their tissue expresses any cancer-related genes or other biological markers. They will also be asked to provide blood samples prior to starting their cancer treatment, and again at 1 month, 3 months, 6 months, 9 months, and 12 months after starting their cancer treatment. Participants may also choose to continue to provide additional blood samples every 3 months for another 3 years after starting their cancer treatment, if they wish. All samples collected for this study will undergo a range of different assessments to identify any cancer-related genes or other biological markers.

Tumour and blood samples will be collected from participants as part of their routine treatment and follow-up. This means no additional blood tests or biopsy procedures will be required for this research project.

It is hoped this research will identify new biological markers that can be used to determine how cancer patients may respond to different treatments, or their risk of cancer relapse post-treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127642 0
A/Prof Surein Arulananda
Address 127642 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 127642 0
Australia
Phone 127642 0
+613 8572 2392
Fax 127642 0
Email 127642 0
surein.arulananda@monashhealth.org
Contact person for public queries
Name 127643 0
Mr Alastair Kwok
Address 127643 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 127643 0
Australia
Phone 127643 0
+613 8572 2584
Fax 127643 0
Email 127643 0
alastair.kwok2@monashhealth.org
Contact person for scientific queries
Name 127644 0
A/Prof Surein Arulananda
Address 127644 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 127644 0
Australia
Phone 127644 0
+613 8572 2392
Fax 127644 0
Email 127644 0
surein.arulananda@monashhealth.org

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.