A prospective pilot trial of sentinel node biopsy for high risk non melanoma skin cancer

Not Applicable

Recruiting

• Conditions: High risk non melanoma skin cancer; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12611000712909
• Lead Sponsor: Sydney Head and Neck Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of clinically negative patients with pathologically positive sentinel lymph nodes (containing metastases).[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 Measures

Name	Time	Method
Treatment related morbidity from sentinel lymph node biopsy. Morbidity will be documented as reported from patient and/or identified by clinical assessment.[Assessed within the first 4 months post op.]