ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001119280

Ethics application status

Approved

Date submitted

14/08/2017

Date registered

6/07/2018

Date last updated

19/08/2019

Date data sharing statement initially provided

19/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry. Australia

Scientific title

Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry in Australia

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1200-6879

Trial acronym

RESIN Registry

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Liver Cancer primary or secondary

Condition category

Condition code

Cancer

Liver

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

Patients will have data collected as part of standard of care insertion of Sir-Spheres for treating their primary or secondary liver tumours. Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends. The study will end when there have been 100 patients enrolled or until the coordinating site decides to shut the study.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Safety- measured by functional stablility of the liver during the course of care as per standard of care procedures such as liver function tests and/or CT Scans of liver depending on the Doctor.

Timepoint [1]

Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends.

Secondary outcome [1]

Tolerability through review of adverse events (abdominal pain and/or pressure
nausea for 1-2 days, temperature, chills, tiredness, loss of appetite) assessed by the Doctor

Timepoint [1]

Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends.

Secondary outcome [2]

Objective response every 6 months until the study ends or patient completes treatment. These will be liver function tests, CT scans of liver

Timepoint [2]

At first treatment then, every 6 months until the study ends, patient completed treatment

Eligibility

Key inclusion criteria

1. Patients who have selected Y90 therapy for the first time to a treat both primary and metastatic diseases of the liver.
2. Provision of written informed consent.
3. Age 18 and older.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients who are being re-treated with Y90, even if new areas are being targeted. If patients have received Y90 treatment as part of their first and ongoing round of Y90 therapy, they are eligible to participate.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The registry will assess real world evidence (RWE) around safety, tolerability,
outcomes and document treatment-related information. The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer.

It is hoped that the study findings will lead to a better understanding of SIR-Spheres treatment patterns; provide additional insights into long-term patient outcomes; and guidefuture SIR-Spheres treatment research, especially for those conditions where data are currently limited or lacking. The study originated in the U.S. with Dr Dan Brown, Vanderbilt University Medical Centre as the study chair, it has since been extended to Australia and New Zealand.The potential participating hospitals or centres that will be involved with the registry are estimated to be 15 Australia-wide with the possibility of future international collaborations.

Recruitment

Recruitment status

Stopped early

Data analysis

No data analysis planned

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

27/06/2017

Date of last participant enrolment

Anticipated

30/08/2022

Actual

26/02/2019

Date of last data collection

Anticipated

30/08/2023

Actual

4/04/2019

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

The Wesley Hospital - Auchenflower

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Westmead Rehabilitation Hospital - Merrylands

Recruitment hospital [4]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [5]

Knox Private Hospital - Wantirna

Recruitment hospital [6]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

4066 - Auchenflower

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

2160 - Merrylands

Recruitment postcode(s) [4]

6009 - Nedlands

Recruitment postcode(s) [5]

3152 - Wantirna

Recruitment postcode(s) [6]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sirtex Technology

Address [1]

Level 33, 101 Miller Street
North Sydney, 2016
NSW
Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Peter Gibbs

Address

Gibbs Lab SB&PM
WEHI
1G Royal Parade
Parkville 3052
Victoria

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Sirtex

Address [1]

Level 33, 101 Miller Street
North Sydney NSW 2060
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

Office for Research 
The Royal Melbourne Hospital 
Level 2 South 300 Grattan Street Parkville 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/11/2016

Approval date [1]

22/12/2016

Ethics approval number [1]

2016.372

Summary

Brief summary

The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and Y90 therapy for the first time as treatment for either primary or secondary liver cancer. 

Study details
The treatment is for primary and secondary liver cancer. The Radiation-Emitting SIR-Spheres In Non-resectable (RESIN) Liver Tumor involves patients with primary and secondary liver cancer receiving (Y90 resin microspheres) treatment as part of their overall oncologic management. The microsphere are injected into the liver through a blood vessel. This allows a large dose of radiation to be delivered to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
All visits and procedures related to SIR-Spheres treatment are performed on an outpatient basis per standard of care. Prior to treatment, patients are assessed by physical examination, radiographic evaluation, and blood tests to determine the health of the patient and liver.

Standard of care tests done before this procedure may include:
• physical exam and medical history
• blood tests requiring about 2 tablespoons of blood
• a chest x-ray, CT or MRI scan 
• an imaging scan (CT or MRI scan) of the liver

Patients undergo an initial mapping arteriogram, to determine the distribution of blood vessels to the tumor(s), identify possible vessels which are to be avoided due to supply to the stomach/small bowel, and evaluate the amount of shunting through the tumor(s) to the lungs. This procedure is performed under sterile conditions with patients having a small tube (catheter) inserted through the skin. It is usually inserted into the thigh, into a blood vessel going to the liver. 

Depending on the size and location of tumors, there may be more than one treatment with SIR-Spheres planned. Repeat treatment is done between 4-8 weeks after the first treatment if there is more disease to treat.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Gibbs

Address

WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia

Country

Australia

Phone

+61393452897

Fax

+61394982010

[email protected]

Contact person for public queries

Name

Maria Edmonds

Address

WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia

Country

Australia

Phone

+61393452896

Fax

+61394982010

[email protected]

Contact person for scientific queries

Name

Maria Edmonds

Address

WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia

Country

Australia

Phone

+61393452896

Fax

+61394892010

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponser level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.

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.

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