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Trial registered on ANZCTR


Registration number
ACTRN12613000122752
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
1/02/2013
Date last updated
1/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A New Test for Detecting Endometrial Cancer
Scientific title
A New Test for Detecting Endometrial Cancer
Secondary ID [1] 281823 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 288173 0
Condition category
Condition code
Cancer 288535 288535 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants admitted for treatment for endometrial cancer (usually involving a hysterectomy) undergo a uterine wash during the gynaecological procedure. The wash, which will take less than 5 minutes to collect, will contain enzymes called matrix metalloproteinases (MMPS), which are released into the uterine cavity in patients with endometrial cancer. Uterine washes will be transported to a test laboratory to be analysed for MMP levels using standard lab techniques. This testing will take a few hours to complete.
Intervention code [1] 286375 0
Early detection / Screening
Comparator / control treatment
The control group is made up of participants who are known to not have endometrial cancer. These participants suffer from unrelated gynaecological conditions that still require them to undergo hysterctomy (ie prolapse). The uterine wash procedure and testing will be performed as that described for patients with endometrial cancer.
Control group
Active

Outcomes
Primary outcome [1] 288694 0
Detection of enodmetrial cancer through measurement of MMP biomarkers levels in uterine wash specimens.
Timepoint [1] 288694 0
The effectiveness of the test will be determined at the end of the study.
Primary outcome [2] 288766 0
To determine the type of MMPs released into the uterine cavity of women with endometrial cancer and in women with other gynecological conditions.
Timepoint [2] 288766 0
The profiles of MMPs will be determined throughout and at the conclusion of the study.
Secondary outcome [1] 300776 0
N/A
Timepoint [1] 300776 0
N/A

Eligibility
Key inclusion criteria
Peri-menopausal and post-menopausal women with endometrial cancer that are undergoing a hysterectomy procedure
Minimum age
45 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Men
- Women who do not have endometiral cancer who do not fit the age range
- Women who are not already having non-cancer gynecological treatment

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)
Patients enrolled as they present to Royal Women's Hospital that are eligible for the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
NA

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
7/03/2012
Actual
7/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 464 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 6215 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286611 0
Commercial sector/Industry
Name [1] 286611 0
Diagnotech Pty Ltd
Country [1] 286611 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Diagnotech Pty Ltd
Address
Level 34
360 Collins St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 285398 0
None
Name [1] 285398 0
None
Address [1] 285398 0
None
Country [1] 285398 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The main aim of this study is to assess the ability of a new test to detect endometrial cancer in post-menopausal women. The diagnostic test being evaluated involves performing a wash of the uterus and collecting this wash fluid for analysis of markers that are shed from cancer cells. Two different laboratory testing methods will be used to obtain information that will enable us to develop a more cost-effective, sensitive and specific test for detecting early stages of endometrial cancer.

Who is it for?
This studyis open to peri- and post-menopausal women aged 45-80 years with endometrial cancer and who are currently undergoing a hystrectomy procedure.

Trial details
In this study you will undergo a uterine wash procedure while under general anesthetic prior to hysterectomy procedure. The wash sample is then tested for specific MMPs.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 37246 0
Prof Michael Quinn
Address 37246 0
Royal Women’s Hospital
Cnr Flemington Rd & Grattan St
Parkville VIC
3052
Country 37246 0
Australia
Phone 37246 0
+61 3 93445188
Fax 37246 0
Email 37246 0
[email protected]
Contact person for public queries
Name 37247 0
Sacha Dopheide
Address 37247 0
81-89 Cotham Rd
Kew, Victoria
3101
Country 37247 0
Australia
Phone 37247 0
+61 3 99457527
Fax 37247 0
Email 37247 0
[email protected]
Contact person for scientific queries
Name 37248 0
Sacha Dopheide
Address 37248 0
81-89 Cotham Rd
Kew, Victoria
3101
Country 37248 0
Australia
Phone 37248 0
+61 3 99457527
Fax 37248 0
Email 37248 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.