Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy for Melanoma Treatment Phase II Study for Therapy of Patients with Early Stage Melanoma

Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy for Melanoma Treatment Phase II Study for Therapy of Patients with Early Stage Melanoma: The effect on tumour recurrence and overall survival

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000549628

Acronym

Sentinel Node Biopsy Melanoma

Enrollment

100

Registered

2005-09-29

Start date

2000-01-01

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

Interventions

Treatment of patients with Early Stage I/II Melanoma using Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy. This treatment has shown a high degree of safety with very few adverse events. The scheduled initial follow-up period will be for 5 years post-surgery.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Stage I and II cutaneous melanoma > 1mm in Breslow thickness or > Clark Level III; Absence of Metastases; Willingness to attend all scheduled clinical visits, tests and blood sampling.

Exclusion criteria

Poor performance status; Pregnancy; Other malignancy.

Outcome results