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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12608000519358
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
3/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification of Protein markers in ovarian cancer
Scientific title
Identification Of Protein Markers Suitable for the early detection of ovarian cancer
Secondary ID [1] 717 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 3687 0
Condition category
Condition code
Cancer 3853 3853 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients undergoing this study will be having an oophorectomy or hysterectomy for a gynecological malignancy or benign condition. The participants will be requested to donate biological samples: blood , tissue, ascites,urine and uterine lavage which does not interfere with other diagnostic tests, nor does it interfere with medical or surgical treatment required. Surgery will be performed in exactly same way, as if the biological samples had not been collected.
Intervention code [1] 3401 0
Early detection / Screening
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4846 0
To measure the different protein levels in ovarian cancer tissue, urine, plasma and uterine lavage. Advanced proteiomic method will be use to identify cancer specific proteins from the collected specimens
Timepoint [1] 4846 0
Specimens will be collected and will be stored untill 500 participants are recruited and than specimens will be processed
Primary outcome [2] 4847 0
Identification of cancer-specific protein markers for the early detection of Ovarian Cancer
Timepoint [2] 4847 0
End of the data anlysis phase
Secondary outcome [1] 8033 0
None
Timepoint [1] 8033 0
None

Eligibility
Key inclusion criteria
Patients who have known Ovarian cancer diagnosed from a previous pathology specimen OR Patients with an Ovarian mass which may be beningn or malignat.
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 3868 0
Charities/Societies/Foundations
Name [1] 3868 0
Ovarian Cancer Research Foundation
Country [1] 3868 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Ovarian cancer research fund
Address
TOK Corporate Centre
Suite 2B
Level 1
459 Toorak Road
Toorak Vic 3142
Country
Australia
Secondary sponsor category [1] 3472 0
None
Name [1] 3472 0
Address [1] 3472 0
Country [1] 3472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5921 0
Sydney South West Area Health Service ERC (Royal Prince Alfred Hospital)
Ethics committee address [1] 5921 0
Royal Prince Alfred Hospital
Building 92, Level 3
Missenden Road
Campberdown
NSW 2050
Ethics committee country [1] 5921 0
Australia
Date submitted for ethics approval [1] 5921 0
Approval date [1] 5921 0
28/08/2008
Ethics approval number [1] 5921 0
x08-0158

Summary
Brief summary
This study aims to identify protein markers that are suitable for allowing early detection of ovarian cancer.

Who is it for?
You can join this study if you have either:
(1) known ovarian cancer diagnosed from a previous pathology specimen.

(2) an ovarian mass which may be benign or malignant.


and you will be having surgical removal of either your ovary or ovaries (oophorectomy or ovariectomy) or your uterus (hysterectomy).

Trial details:
Participants will be requested to donate biological samples: blood, tissue, ascites (peritoneal cavity fluid), urine and uterine lavage (washings). This does not interfere with other diagnostic tests, or with the required medical or surgical treatment. Surgery will be performed in exactly same way, as if the samples had not been collected.

Detection of ovarian cancer at its earliest stages provides a good prognosis for full recovery; however survival diminishes greatly when the cancer spreads beyond the ovary. Current ovarian cancer markers lack the accuracy needed to provide a suitable early detection test. This study uses new procedures to identify a number of candidate blood protein markers produced by ovarian cancers which may be suitable as early cancer markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28930 0
Address 28930 0
Country 28930 0
Phone 28930 0
Fax 28930 0
Email 28930 0
Contact person for public queries
Name 12087 0
Dr. Philip Beale
Address 12087 0
Royal Prince Alfred Hospital [RPAH]
Sydney Cancer Centre
Level 6 Gloucester House
Missenden Road
Camperdown
NSW 2050
Country 12087 0
Australia
Phone 12087 0
02 9515 6183
Fax 12087 0
02 9515 5063
Email 12087 0
[email protected]
Contact person for scientific queries
Name 3015 0
Dr. Philip Beale
Address 3015 0
Royal Prince Alfred Hospital [RPAH]
Sydney Cancer Centre
Level 6 Gloucester house
Missenden road
Camperdown
NSW 2050
Country 3015 0
Australia
Phone 3015 0
02 9515 6183
Fax 3015 0
02 9515 5063
Email 3015 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.