Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12605000259640
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
New approaches in genetic analysis to predict for CRC risk.
Scientific title
High Throughput Screening for Genetic Analysis of Colorectal Cancer Risk
Secondary ID [1] 286627 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer 346 0
Condition category
Condition code
Cancer 399 399 0 0
Bowel - Anal
Cancer 400 400 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 401 401 0 0
Bowel - Small bowel (duodenum and ileum

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this research is to find the undiscovered gene or genes responsible for hereditary colorectal cancer, and to understand how the gene(s) cause colorectal cancer. One of the best approaches used to find the answers to these questions is to study families where there are several family members affected with colorectal cancer.
Case probands and their relatives (affected and unaffected) will be recruited
(20 ml) of blood will be obtained on one occasion from each participant
Where tissues from affected family members have already been obtained (paraffin embedded tumour tissue in blocks) we will seek permission to access this material for DNA extraction. The duration of study will be approximately 48 months.
Intervention code [1] 328 0
Early detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 460 0
To identify molecular markers of potential value in understanding predisposition to CRC by their association with gene variants that increase the risk of CRC.
The study will be a family based analysis of SNP genotypes for cases and controls within families and between families. Transmission of disease associated SNPs will be assessed to determine within-family association and linkage and then to calculate across-family associations.
Timepoint [1] 460 0
2-3 blood samples per week over 36 months approx
Secondary outcome [1] 1001 0
If linkage is found then comparisons between families will be undertaken to determine whether the same SNP allele (or alleles) is associated in other families, thus providing a direct indicator of CRC risk. If this is the case, further testing in different ethnic groups may be necessary to extend the findings more broadly
Timepoint [1] 1001 0
Nil

Eligibility
Key inclusion criteria
Cancer patients:1: Patients from families with 3 or more first-degree relatives having CRC, with one diagnosed less than 50 years of age. 2: Patients from families with 2 or more first-degree relatives having CRC. 3: Patients from families with one first degree and one or more second-degree relatives having CRC.Unaffected Individuals:1: First-degree relatives, over 70 years of age, from the above families who have no history of colorectal neoplasia.2:Younger first-degree relatives, at least 50 years of age, who are colonoscopy negative.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/09/2004
Actual
14/10/2004
Date of last participant enrolment
Anticipated
Actual
9/10/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 451 0
Government body
Name [1] 451 0
CSIRO Australia
Country [1] 451 0
Australia
Primary sponsor type
Government body
Name
CSIRO, Australia
Address
CSIRO Molecular and Health Technologies PO Box 184 North Ryde NSW, 1670
Country
Australia
Secondary sponsor category [1] 368 0
Individual
Name [1] 368 0
Prof. Graeme Young MD, FRACP,
Address [1] 368 0
Department of Gastroenterology Flinders Medical Centre Bedford Park 5042
Country [1] 368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1425 0
Flinders Medical Centre
Ethics committee address [1] 1425 0
Adelaide
Ethics committee country [1] 1425 0
Australia
Date submitted for ethics approval [1] 1425 0
Approval date [1] 1425 0
01/05/2004
Ethics approval number [1] 1425 0
Ethics committee name [2] 1426 0
The Royal Melbourne Hospital
Ethics committee address [2] 1426 0
Melbourne
Ethics committee country [2] 1426 0
Australia
Date submitted for ethics approval [2] 1426 0
Approval date [2] 1426 0
Ethics approval number [2] 1426 0
Ethics committee name [3] 1427 0
CSIRO Molecular Science
Ethics committee address [3] 1427 0
Sydney
Ethics committee country [3] 1427 0
Australia
Date submitted for ethics approval [3] 1427 0
Approval date [3] 1427 0
Ethics approval number [3] 1427 0
Ethics committee name [4] 1428 0
CSIRO Mathematical and Information Sciences
Ethics committee address [4] 1428 0
Ethics committee country [4] 1428 0
Date submitted for ethics approval [4] 1428 0
Approval date [4] 1428 0
Ethics approval number [4] 1428 0

Summary
Brief summary
To find the undiscovered gene or genes responsible for hereditary colorectal cancer, and to understand how the gene(s) cause colorectal cancer.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 35774 0
Prof Graeme P Young
Address 35774 0
Department of Gastroenterology
1 Flinders Drive
Flinders Medical Centre
Bedford Park
SA 5042
Country 35774 0
Australia
Phone 35774 0
+61882044963
Fax 35774 0
Email 35774 0
[email protected]
Contact person for public queries
Name 9517 0
Ms Jane Upton
Address 9517 0
Department of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country 9517 0
Australia
Phone 9517 0
+61 8 82046071
Fax 9517 0
+61 8 82046330
Email 9517 0
[email protected]
Contact person for scientific queries
Name 445 0
Prof. Graeme Young
Address 445 0
Department of Medicine (Gastroenterology)
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country 445 0
Australia
Phone 445 0
+61 8 82044964
Fax 445 0
+61 8 82043943
Email 445 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.