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NCT Number: NCT05900102

Head and Neck Melanoma; Access to Staging and Surgical Treatment

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.

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Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Academic Plastic Surgery, Hull University Teaching Hospitals NHS TRust

Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 1. What proportion of patients diagnosed with cutaneous melanoma of the head and neck go on to have SLNB?

    Time frame: 5 years

  2. 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?

    Time frame: 5 years

Secondary outcomes

  1. 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?

    Time frame: 5 years

  2. 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?

    Time frame: 5 years

  3. 3. Is there a variation in provision of SLNB for cutaneous melanoma of the head and neck across England?

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

Evaluating the Current Standard of Care for Patients Diagnosed With Malignant Melanoma of the Head and Neck - Access to Staging and Surgical Treatment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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