Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000712909
Ethics application status
Approved
Date submitted
7/06/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective pilot trial of sentinel node biopsy for high risk non melanoma skin cancer
Scientific title
A non-randomised pilot study to assess feasibility of sentinel lymph node biopsy (SLNB) for patients with high risk clinicopathologic features of cutaneous squamous cell carcinoma.
Secondary ID [1] 262337 0
nil
Universal Trial Number (UTN)
U1111-1118-3627
Trial acronym
SNIC trial (pilot phase)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk non melanoma skin cancer 268040 0
Condition category
Condition code
Cancer 268172 268172 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with non melanoma skin cancer and clinicopathologic risk factors for developing regional lymph node metastases will receive sentinel lymph node biopsy followed by completion lymphadenectomy for positive pathological nodes, or continued observation if negative.

All patients will be followed for 5 years post SLNB procedure.
Intervention code [1] 266726 0
Early detection / Screening
Intervention code [2] 266814 0
Treatment: Surgery
Intervention code [3] 266815 0
Diagnosis / Prognosis
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266918 0
Percentage of clinically negative patients with pathologically positive sentinel lymph nodes (containing metastases).
Timepoint [1] 266918 0
follow up will be ongoing for 5 years, or until death. Follow up will be every 4 months for the first two years, then every 6 months for the remaining 3 years.
Secondary outcome [1] 276624 0
Treatment related morbidity from sentinel lymph node biopsy. Morbidity will be documented as reported from patient and/or identified by clinical assessment.
Timepoint [1] 276624 0
Assessed within the first 4 months post op.

Eligibility
Key inclusion criteria
Participants must be able to give fully informed consent and have non melanoma skin cancer with any of the following clinicopathologic risk factors:
-size > 2cm -invasion into subcutaneous fat or tumour thickness > 5mm -poorly differentiated phenotype
-perineural invasion
-lymphovascular invasion
-local recurrence
-location of lesion on lip or ear
-immunocomprimised host (post organ transplant, chemotherapy)
-carcinoma developing in pre-existing scar
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects meeting any of the following criteria will be excluded from participation:
-Clinical evidence of distant metastases
-previous surgery that is believed to have altered the local lymphatic drainage since emergence of lesion
-allergy to patent blue dye or radiocolloid
-inability to complete 5 years of follow up
-Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
-significant cognitive or psychiatric disorder (inability to understand informed consent)
-pregnancy/lactation

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 meeting inclusion criteria will be informed of the trial, receive patient information sheet, and be required to sign consent form prior to study participation.
Enrolled patients will receive a lymphoscintigraphy mapping procedure within 24hrs of surgery for wide local excision of the cutaneous primary site and the sentinel lymph node biopsy procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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
24/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 3618 0
New Zealand
State/province [1] 3618 0
Auckland

Funding & Sponsors
Funding source category [1] 267215 0
Self funded/Unfunded
Name [1] 267215 0
Country [1] 267215 0
Primary sponsor type
Charities/Societies/Foundations
Name
Sydney Head and Neck Cancer Institute
Address
PO Box 142
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 266282 0
None
Name [1] 266282 0
nil
Address [1] 266282 0
Country [1] 266282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269206 0
Sydney Local Health Network Ethics Review Committee (RPAH zone)
Ethics committee address [1] 269206 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 269206 0
Australia
Date submitted for ethics approval [1] 269206 0
Approval date [1] 269206 0
03/12/2009
Ethics approval number [1] 269206 0
HREC/09RPAH/547

Summary
Brief summary
This study aims to determine the safety, efficacy, and feasibility of sentinel lymph node biopsy for people with high risk non melanoma skin cancer.

Who is it for?
You can join this study if you are aged 18 years or more, have high risk non melanoma skin cancer, and will be available for a 5 year follow-up assessment.

Trial details
Participants in this trial will receive wide local excision of their skin cancer and sentinel lymph node biopsy (SLNB). SLNB is a procedure in which the local lymph node ("gland") that drain the patch of skin containing the tumour are excised. These lymph node(s) are examined under a microscope to determine whether cancer cells are present. If cancer cells are found, patients will undergo completion lymphadenectomy (i.e. surgical removal of the rest of the regional lymph nodes).

This trial will evaluate the rates of positive sentinel lymph nodes in patients with high risk non melanoma skin cancer and assess morbidity or injury associated with the sentinel lymph node biopsy procedure.
Trial website
http://www.shnci.org/Pages/research03.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32715 0
Address 32715 0
Country 32715 0
Phone 32715 0
Fax 32715 0
Email 32715 0
Contact person for public queries
Name 15962 0
Sarah Davies
Address 15962 0
Sydney Head and Neck Cancer Institute
PO Box M142
Missenden Road
Camperdown
NSW 2050
Country 15962 0
Australia
Phone 15962 0
61 2 9515 7535
Fax 15962 0
61 2 9515 7483
Email 15962 0
snictrial@gmail.com
Contact person for scientific queries
Name 6890 0
Jonathan Clark
Address 6890 0
Sydney Head and Neck Cancer Institute
PO Box M142
Missenden Road
Camperdown
NSW 2050
Country 6890 0
Australia
Phone 6890 0
61 2 9553 8827
Fax 6890 0
61 2 9515 7483
Email 6890 0
snictrial@gmail.com

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.