Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000404224
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
21/03/2018
Date last updated
21/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Recurrent and Advance Colorectal Cancer (TRACC): A prospective multi-site registry
Scientific title
Treatment of Recurrent and Advance Colorectal Cancer (TRACC): A prospective multi-site registry
Secondary ID [1] 291687 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TRACC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer 302595 0
Condition category
Condition code
Cancer 302115 302115 0 0
Bowel - Anal
Cancer 302116 302116 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 302117 302117 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Years
Description of intervention(s) / exposure
Registry of metastatic colorectal cancer (mCRC) patients across multiple sites in Australia. To evaluate the presentation, treatment, and outcomes of consective patients with recently diagnosed mCRC managed in routine care and to compare the characteristics and clinical outcomes in patients who do and who do not receive surgery or systemic treatment as part of their treatment regime.
Intervention code [1] 297586 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301555 0
To evaluate the presentation of patients with recently diagnosed mCRC managed in routine clinical practice, by reviewing patient medical records
Timepoint [1] 301555 0
At routine clinic visits till loss to follow up of death.
Primary outcome [2] 301749 0
To evaluate the treatment of patients with recently diagnosed mCRC managed in routine clinical practice by reviewing patient medical records,
Timepoint [2] 301749 0
At time of treatment
Secondary outcome [1] 333019 0
The following end-points will be evaluated in this study:
Time to progression (TTP), from primary diagnosis by reviewing pt medical records
Timepoint [1] 333019 0
At routine clinic visits
Secondary outcome [2] 333760 0
Progression-free survival (PFS) by reviewing patient medical records
Timepoint [2] 333760 0
At routine clinic visit
Secondary outcome [3] 333761 0
Overall survival (OS) by reviewing patient medical records
Timepoint [3] 333761 0
At routine clinic visits

Eligibility
Key inclusion criteria
Patients of any age and any ECOG performance status with locally recurrent or metastatic CRC, either recurrent or de novo metastatic disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients first diagnosed with mCRC more than 6 months ago

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As the aim of this project is to better understand the treatment and outcomes of mCRC, for which there is currently very little data, there is no formal statistical plan. It is anticipated that a sample size of 2500 is sufficient to achieve the aim of this study, and to achieve preliminary insights into variation in practice and outcomes across sites.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/03/2009
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
3000
Accrual to date
2589
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 7703 0
The Canberra Hospital - Garran
Recruitment hospital [2] 7704 0
Calvary Private Hospital ACT - Bruce
Recruitment hospital [3] 7705 0
National Capital Private Hospital - Garran
Recruitment hospital [4] 7706 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 7707 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [6] 7708 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 7709 0
Launceston General Hospital - Launceston
Recruitment hospital [8] 7710 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [9] 7712 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 7713 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [11] 7714 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 15626 0
2605 - Garran
Recruitment postcode(s) [2] 15627 0
2617 - Bruce
Recruitment postcode(s) [3] 15628 0
5042 - Bedford Park
Recruitment postcode(s) [4] 15629 0
5011 - Woodville
Recruitment postcode(s) [5] 15630 0
7000 - Hobart
Recruitment postcode(s) [6] 15631 0
7250 - Launceston
Recruitment postcode(s) [7] 15632 0
4029 - Herston
Recruitment postcode(s) [8] 15634 0
4215 - Southport
Recruitment postcode(s) [9] 15635 0
6008 - Subiaco
Recruitment postcode(s) [10] 15636 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 8757 0
Hong Kong
State/province [1] 8757 0
Hong Kong

Funding & Sponsors
Funding source category [1] 295994 0
Other
Name [1] 295994 0
Biogrid
Country [1] 295994 0
Australia
Primary sponsor type
Other
Name
Biogrid
Address
Level 8, CMR Building, Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 294879 0
None
Name [1] 294879 0
Address [1] 294879 0
Country [1] 294879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297255 0
Research Office Melbourne Health
Ethics committee address [1] 297255 0
Royal Melbourne Hospital
Grattan Street
Parkville
Victoria 3050
Ethics committee country [1] 297255 0
Australia
Date submitted for ethics approval [1] 297255 0
24/03/2009
Approval date [1] 297255 0
24/03/2009
Ethics approval number [1] 297255 0
2009/113

Summary
Brief summary
The primary purpose of this study is to set up a registry of patients with recurrent and advanced colorectal cancer to evaluate patterns in the presentation, treatment and outcomes of the disease. It is for patients over the age of 18. Researchers will collect information relating to the presentation and characteristics of each participant's disease and information on treatments received and response to treatment by reviewing medical records. It is hoped that the findings from the registry will enhance our understanding of how treatments received and the timings of these treatments affect disease outcomes, and how these relate to the presentation and characteristics of colorectal cancers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73478 0
Prof Peter Gibbs
Address 73478 0
Gibbs Laboratory
Walter &Eliza Hall Institute
1 G Royal Parade
Parkville 3052
Victoria
Country 73478 0
Australia
Phone 73478 0
+61 3 93452897
Fax 73478 0
+61 3 94982010
Email 73478 0
[email protected]
Contact person for public queries
Name 73479 0
Mr Michael Harold
Address 73479 0
Gibbs Laboratory
Walter &Eliza Hall Institute
1 G Royal Parade
Parkville 3052
Victoria
Country 73479 0
Australia
Phone 73479 0
+61 3 93452799
Fax 73479 0
+61 3 94982010
Email 73479 0
[email protected]
Contact person for scientific queries
Name 73480 0
Dr Belinda Lee
Address 73480 0
Gibbs Laboratory
Walter &Eliza Hall Institute
1 G Royal Parade
Parkville 3052
Victoria
Country 73480 0
Australia
Phone 73480 0
+61 3 93452893
Fax 73480 0
+61 3 98942010
Email 73480 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

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