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Trial Title:
EVALUATING THE CURRENT STANDARD OF CARE FOR PATIENTS DIAGNOSED WITH MALIGNANT MELANOMA OF THE HEAD AND NECK - ACCESS TO STAGING AND SURGICAL TREATMENT
NCT ID:
NCT05900102
Condition:
Melanoma (Skin)
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Hull University Teaching Hospitals NHS Trust
Agency class:
Other
Source:
Hull University Teaching Hospitals NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900102