Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001553268
Ethics application status
Approved
Date submitted
27/06/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metastatic Access Research Collaboration (MonARC) for collection of post-mortem tissue
Scientific title
Metastatic Access Research Collaboration for collection of post-mortem tissue
Secondary ID [1] 295342 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MonARC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Cancers 308548 0
Condition category
Condition code
Cancer 307516 307516 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Metastatic Access Research Collaboration (MonARC) study is research project that aims to improve knowledge around the way that cancer spreads and becomes resistant to treatment. In this study, we seek permission to obtain and study samples of tissue from patients who have recently died of their cancer. This procedure is called an autopsy or post-mortem examination.

Should you have terminal cancer and wish to consent to the project, a blood sample (40ml) will be taken after you consent. This will be to perform laboratory tests about your DNA.

Samples will be collected during the autopsy from sites containing cancerous cells. The study team will follow the request of the participant or their family if certain body sections are not to be removed.

Following the autopsy, samples may be used in projects that are currently Human Research Ethics Committee (HREC) approved or stored for future research (a "Biobank"). Tissues will be stored indefinitely until used for research. Health information or biological samples will NOT be used on research project without the permission of a Human Research Ethics Committee.
Intervention code [1] 301665 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306489 0
Number of cancerous tissue available for medical research
Timepoint [1] 306489 0
3 years
Secondary outcome [1] 349395 0
Number of patient derived xenograph models of cancer
Timepoint [1] 349395 0
3 years

Eligibility
Key inclusion criteria
1, Metastatic malignancy
2, Ability to make informed consent
3, Have received and understood information from their treating doctor that their disease is terminal
4. Are treated or have been seen at a Participating Site, engaging in services including but not limited to medical oncology, palliative care or allied health.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. There is concern that involvement will have negative psychological impact on the individual or his/her family.
2. They are currently incarcerated
3. They have unstable psychiatric illness
4. A health-care provider (HCP) involved in the patient care OR any listed study personnel, feels that the autopsy is inappropriate

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is an exploratory study and no power calculations are provided.

The study team expect that less that 20% of eligible participants will consent. Furthermore, if after the participant death, a family member does not wish for the procedure to be performed, we will not proceed with autopsy.

Statistically significant information is expected from low number of participants. Campbell et al. (2010) showed unparalleled view of the timing, sequence and diversity of changes in pancreatic cancer with only 17 pancreatic cancer patients who underwent rapid autopsy.

It is therefore expected 100 patients across all cancer types will provide useful insights into the spreading of cancer types and development of resistance to treatment .

Campbell, P.J., et al., The patterns and dynamics of genomic instability in metastatic pancreatic cancer. Nature, 2010. 467(7319): p. 1109-1113.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/02/2018
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
100
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11255 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23132 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299935 0
Hospital
Name [1] 299935 0
St Vincent's Hospital Sydney
Country [1] 299935 0
Australia
Funding source category [2] 299936 0
Other Collaborative groups
Name [2] 299936 0
Garvan Institute of Medical Research
Country [2] 299936 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 299311 0
None
Name [1] 299311 0
Address [1] 299311 0
Country [1] 299311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300801 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 300801 0
390 Victoria St
Darlinghurst
NSW 2010
Ethics committee country [1] 300801 0
Date submitted for ethics approval [1] 300801 0
10/08/2017
Approval date [1] 300801 0
12/09/2017
Ethics approval number [1] 300801 0
HREC/17/SVH254

Summary
Brief summary
The purpose of this research is to:
1. Create a library (“biorepository”) of cancer samples to use in future research projects.
2. Collect medical information about patients to put with the cancer samples.
3. Keep some cells to grow in the laboratory (“cell lines”) and grow pieces of cancer tissue in specially bred mice (“xenografting”).

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with metastatic cancer.

Study details

Participants will be asked to provide a 40ml sample of blood after they have consented to the research and in the future allow for tissue collection post mortem.

It is hoped that this research will provide important information on how cancer cells grow, change over time and spread. This information is essential to help design more effective therapies for cancer patients in the future.

This research is being conducted by the Garvan Institute of Medical Research and The Kinghorn Cancer Centre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84858 0
Prof Anthony Joshua
Address 84858 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84858 0
Australia
Phone 84858 0
+61 2 9355 5600
Fax 84858 0
+61 2 9355 5735
Email 84858 0
[email protected]
Contact person for public queries
Name 84859 0
Mr Robert Kent
Address 84859 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84859 0
Australia
Phone 84859 0
+61 2 9355 5600
Fax 84859 0
+61 2 9355 5735
Email 84859 0
[email protected]
Contact person for scientific queries
Name 84860 0
Prof Anthony Joshua
Address 84860 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84860 0
Australia
Phone 84860 0
+61 2 9355 5600
Fax 84860 0
+61 2 9355 5735
Email 84860 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.