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

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000712909

Acronym

SNIC trial (pilot phase)

Enrollment

Registered

2011-07-11

Start date

2010-02-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results