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Trial registered on ANZCTR


Registration number
ACTRN12614000135617
Ethics application status
Approved
Date submitted
28/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Uterine fluid lactate dehydrogenase isoenzyme activity profile. Can it be considered a diagnostic marker for endometrial cancer?
Scientific title
Uterine fluid lactate dehydrogenase isoenzyme activity profile. Can it be considered a diagnostic marker for endometrial cancer? A prospective controlled clinical trial
Secondary ID [1] 283985 0
3/26 faculty of medicine Alexandria university registration number
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometrial cancer 291014 0
Condition category
Condition code
Cancer 291359 291359 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200 Postmenopausal women with one or more episode of vaginal bleeding will be included after signing informed consent.

The transvaginal ultrasonography (TVS ) and uterine fluid sampling for lactate dehydrogenase ( LD ) isoenzyme analysis will be performed as office examinations taking about 30 minutes on the same setting.

Endometrial thickness will be classified as >5 mm or <5 mm on TVS.

Patients with endometrial thickness >5 mm on TVS will be evaluated with diagnostic curettage, and those with endometrial thickness <5 mm will be evaluated with office endometrial biopsy usually within one week . LD isoenzyme profile will subsequently be related to histopathological diagnosis.
Intervention code [1] 288672 0
Diagnosis / Prognosis
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291355 0
diagnostic accuracy of LD isoenzyme activity in post menopausal uterine bleeding for early detection of endometrial cancer compared to histopathological examination of endometrial tissues.
Timepoint [1] 291355 0
after histopathological examination of endometrial tissues have been completed.
Secondary outcome [1] 306582 0
assessment of accuracy of LD isoenzyme activity in endometrial thickness less than and above 5 mm through comparison with histopathological examination of endometrial tissues.
Timepoint [1] 306582 0
Immediately after histopathological examination of endometrial tissues have been completed.

Eligibility
Key inclusion criteria
females with postmenopausal uterine bleeding
even one episode of bleeding will be included in the study
Minimum age
45 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with recent endometrial sampling.
Current hormone replacement therapy
Uterine fluid collection at TVS
Clinical signs of endometritis

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
power of the study and sample size were calculated through analysis of the incidence of endometrial cancer in postmenopausal bleeding with accepted error of 10 % and comfidence interval 95%

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/02/2014
Actual
Date of last participant enrolment
Anticipated
15/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 5778 0
Egypt
State/province [1] 5778 0
alexandria

Funding & Sponsors
Funding source category [1] 288613 0
Self funded/Unfunded
Name [1] 288613 0
Country [1] 288613 0
Egypt
Primary sponsor type
University
Name
alexandria univerisity
Address
22 elgeish street , elshatby
Alexandria , egypt
21526
Country
Egypt
Secondary sponsor category [1] 287321 0
None
Name [1] 287321 0
Address [1] 287321 0
Country [1] 287321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290472 0
ethical committee , faculty of medicine ,alexandria university
Ethics committee address [1] 290472 0
Champollion Street

El-Khartoum Square

Azarita Medical Campus alexandria egypt
21526
Ethics committee country [1] 290472 0
Date submitted for ethics approval [1] 290472 0
Approval date [1] 290472 0
25/12/2013
Ethics approval number [1] 290472 0
IRB 00007555-fwa no : 00015712

Summary
Brief summary
A new test for diagnosis and early detection of endometrial cancer
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45862 0
Dr ahmed fawzy galal
Address 45862 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 45862 0
Egypt
Phone 45862 0
+201222286962
Fax 45862 0
Email 45862 0
[email protected]
Contact person for public queries
Name 45863 0
ahmed fawzy galal
Address 45863 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 45863 0
Egypt
Phone 45863 0
+201222286962
Fax 45863 0
Email 45863 0
[email protected]
Contact person for scientific queries
Name 45864 0
ahmed fawzy galal
Address 45864 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 45864 0
Egypt
Phone 45864 0
+201222286962
Fax 45864 0
Email 45864 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.