EVALUATING THE CURRENT STANDARD OF CARE FOR PATIENTS DIAGNOSED WITH MALIGNANT MELANOMA OF THE HEAD AND NECK - ACCESS TO STAGING AND SURGICAL TREATMENT

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900102
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2023
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: Joshua P Totty, MBBS MRCS MD(Res) FHEA
• Phone: 01482461883
• Email: joshua.totty[@]hyms.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. What proportion of patients diagnosed with cutaneous melanoma of the head and neck go on to have SLNB?		5 years
Primary	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?		5 years
Secondary	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?		5 years
Secondary	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?		5 years
Secondary	3. Is there a variation in provision of SLNB for cutaneous melanoma of the head and neck across England?		5 years