Clinical trial NCT05900102: Head and Neck Melanoma; Access to Staging and Surgical Treatment
Official title: Evaluating the Current Standard of Care for Patients Diagnosed With Malignant Melanoma of the Head and Neck - Access to Staging and Surgical Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Melanoma
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2023-06-12
Enrollment: 86000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated by the NHS in England over 18 years of age diagnosed with cutaneous melanoma of the head and neck, and of the trunk or limbs.

Brief summary: Melanoma is a serious type of skin cancer and is the 5th most common cancer in the United Kingdom (UK). It can affect anywhere on the skin including on the head and neck. The cancer often is first noticed as an abnormal mole. Treatment is by removing the cancer with surgery. Early spread of the cancer can be found by testing nearby glands called lymph nodes. This operation is called a sentinel lymph node biopsy (SLNB). If the cancer has spread then new treatments, such as immunotherapy, can be given to help the person live for longer.

The sentinel lymph nodes are usually in the armpits or groin for melanoma on the body, arms or legs. For cancers in the head and neck the sentinel lymph nodes will usually be in the neck. For several reasons SLNB in the neck is not offered in every hospital that manages patients with melanoma. The problem with this is that some patients who could benefit are not offered the new treatments that extend life because it is not known that their cancer has spread.

In this study we aim to gather national data on the management of melanoma of the head and neck including variation in practice between different hospitals. We will use routinely collected anonymous data called 'Hospital Episode Statistics' to look at who is offered SLNB after melanoma of the head or neck, what treatments they have, if their melanoma comes back and how long they survive for.

By doing this, we hope to identify whether SLNB should be made available to everyone diagnosed with melanoma of the head and neck.


Eligibility criteria: Inclusion Criteria:

We will use recorded ICD-10 codes to identify patients for the study. All patients over 18 years of age will be included in the study if they have been coded as:

C43.0 Malignant melanoma of lip C43.1 Malignant melanoma of eyelid, including canthus C43.2 Malignant melanoma of ear and external auricular canal C43.3 Malignant melanoma of other and unspecified parts of face C43.4 Malignant melanoma of scalp and neck C43.5 Malignant melanoma of trunk C43.6 Malignant melanoma of upper limb, including shoulder C43.7 Malignant melanoma of lower limb, including hip

Exclusion Criteria:

N/A

Primary outcomes:
measure: 1. What proportion of patients diagnosed with cutaneous melanoma of the head and neck go on to have SLNB?
timeFrame: 5 years
measure: 2. How does this compare to the proportion of patients with cutaneous melanoma in other parts of the body that go on to have SLNB?
timeFrame: 5 years
Secondary outcomes:
measure: 1. What is the tumour stage of patients with cutaneous melanoma of the head and neck who have SLNB compared to those who do not?
timeFrame: 5 years
measure: 2. Do a higher proportion of patients with cutaneous melanoma of the head and neck who have had an SLNB have systemic anti-cancer therapies (or other treatments) for comparable T stage?
timeFrame: 5 years
measure: 3. Is there a variation in provision of SLNB for cutaneous melanoma of the head and neck across England?
timeFrame: 5 years
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Department of Academic Plastic Surgery, Hull University Teaching Hospitals NHS TRust
state: East Riding Of Yorkshire
Study officials:
References: