Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001279819
Ethics application status
Approved
Date submitted
10/12/2012
Date registered
11/12/2012
Date last updated
11/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Feasibility Study Of The Role Of Sentinel Lymph Node Detection In The Management Of Patients With Apparent Early Stage Endometrial Cancer
Scientific title
A Feasibility Study Of The Role Of Sentinel Lymph Node Detection In The Management Of Patients With Apparent Early Stage Endometrial Cancer
Secondary ID [1] 281641 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 287921 0
Condition category
Condition code
Cancer 288301 288301 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intra-cervical injection technique using radio-colloid and Patent Blue dye will be used for SLN mapping. The radio-colloid injection will be carried out on the day of the procedure and pre-operative lymphoscintigraphy with SPECT-CT will be obtained. Patients who have consented to the trial will be brought to the Nuclear Medicine Department at Royal Melbourne Hospital on the day of their planned surgery. In a similar manner to performing a pap smear, the cervix will be injected with 2mls of the radiocolloid, Technetium 99 at the 12, 3, 6 and 9 o’clock position. After the speculum is removed the patients will be asked to complete a Visual Analogue Score to assess pain related to the injection. The SPECT-CT will then be performed to track the route and nodal uptake of the radiocolloid and this information will be returned with the patient to the operating theatre. Under general anaesthetic after initial inspection of the peritoneal cavity, a gamma probe will be used to locate any hot nodes (at least 10 x the background activity). Two millilitres of Patent Blue dye will be injected into the cervix at the 3 and 9 o’clock positions. The SLN biopsy will be carried out prior to the hysterectomy and any nodes which are hot, blue, or both hot and blue will be removed and be set aside for separate histological examination. Hot nodes will be confirmed ex vivo (by counting activity for 3 to 10 seconds) and the nodal basins will be checked for any further nodes. All identified sentinel nodes will be removed and their location noted.
Women with presumed low risk disease will undergo a hysterectomy and bilateral salpingo-oophorectomy and only SLN identified at the time of the procedure will be removed.
Intervention code [1] 286172 0
Treatment: Surgery
Comparator / control treatment
The standard care for these patients includes a hysterectomy (+/- removal of the ovaries) followed by frozen section and depending on this result lymph node dissection. In this study standard of care (as above) will be followed for those patients where cancer is identified at frozen section however only the sentinel node that was identifed during the scan will be removed. Other nodes will only be removed if indicated.

Frozen section will only be done once, before lymph node dissection in standard of care and before sentinel node dissection in this study.
Control group
Active

Outcomes
Primary outcome [1] 288476 0
To determine the proportion of eligible patients in whom sentinel lymph nodes are identified successfully at the time of the surgery using the interventions outlined in the study.
Timepoint [1] 288476 0
At time of surgery
Secondary outcome [1] 300267 0
To identify the location of Sentinel Lymph Nodes in women with endometrial cancer and complex atypical hyperplasia using the interventions outlined in the study.
Timepoint [1] 300267 0
At time of surgery

Eligibility
Key inclusion criteria
Histologically confirmed endometrial cancer
Histologically confirmed complex atypical endometrial hyperplasia
Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected lymph node metastasis on preoperative MRI based on pre-set criteria
Any contra-indications to formal staging surgery e.g. co-morbidities
Inability to give informed consent
Poor understanding of English in absence of an interpreter
Inaccessible for follow up
Allergy to isotope or dye used
Previous cervical surgery like conisation
Age = 18 years
Evidence of metastatic disease

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is feasibility study with no randomisation intended at recruitment. It is hoped that this study will form the basis of a larger study (preferably multicentre) which would allow a calculation of the sensitivity and specificity of sentinel node detection in an Australian population.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
13/08/2012
Date of last participant enrolment
Anticipated
1/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 307 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 6114 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286443 0
Hospital
Name [1] 286443 0
The Royal Women's Hospital Oncology Research Fund
Country [1] 286443 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
20 Flemington Road, Parkville
Victoria, 3052
Country
Australia
Secondary sponsor category [1] 285230 0
None
Name [1] 285230 0
Address [1] 285230 0
Country [1] 285230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288520 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 288520 0
Ethics committee country [1] 288520 0
Australia
Date submitted for ethics approval [1] 288520 0
Approval date [1] 288520 0
14/05/2012
Ethics approval number [1] 288520 0
12/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36470 0
Miss Orla McNally
Address 36470 0
Royal Women's Hospital
Oncology and Dysplasia Unit - 5N
20 Flemington Road, Parkville
Victoria, 3052
Country 36470 0
Australia
Phone 36470 0
+610383452194
Fax 36470 0
Email 36470 0
orla.mcnally@thewomens.org.au
Contact person for public queries
Name 36471 0
Sara Scalzo
Address 36471 0
Royal Women's Hospital
Oncology and Dysplasia Unit - 5N
20 Flemington Road, Parkville
Victoria, 3052
Country 36471 0
Australia
Phone 36471 0
+610383453546
Fax 36471 0
Email 36471 0
sara.scalzo@thewomens.org.au
Contact person for scientific queries
Name 36472 0
Orla McNally
Address 36472 0
Royal Women's Hospital
Oncology and Dysplasia Unit - 5N
20 Flemington Road, Parkville
Victoria, 3052
Country 36472 0
Australia
Phone 36472 0
+610383452194
Fax 36472 0
Email 36472 0
orla.mcnally@thewomens.org.au

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.