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NCT06414343Not yet recruiting

LATe TreatmENT Related Toxicity in Melanoma (LATENT)

Royal Marsden NHS Foundation TrustClinicalTrials.govother
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
Observational - no intervention
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Royal Marsden NHS Foundation Trust
Location
Chelsea, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Dec 01, 2024
Enrollment
400 participants
Primary outcome

To describe patterns of a range of medical late toxicities following immunotherapy treatment for advanced melanoma patients

Summary

Recent improvements in advanced melanoma treatment with immunotherapy have dramatically
 improved patient survival. Longer survival however has come at a cost of toxicity. Short term
 side effects can occur in 50% of patients undergoing immunotherapy treatment; however, many
 long-term survivors are also living with serious consequences of these treatments which may
 be under reported in literature.
 
 Data regarding long term toxicities, from these treatments is lacking and an area of
 important unmet clinical need. Therefore, in collaboration with the Clatterbridge and
 Christie's teams, the investigators propose to retrospectively analyse the nature, incidence,
 frequency, and severity of immune related toxicities in around 400 patients who received
 immunotherapy for advanced melanoma with ongoing durable responses to treatment of at least 3
 years.
 
 The investigators will set up a collective anonymized database and record this information
 through review of electronic medical records of patients that meet the eligibility criteria.
 The investigators will also review the patterns of use of long-term immunosuppression and
 assess the need for specialist referrals for managing late side effects.
 
 The investigators hope that this data will help us address gaps in the management of
 long-term survivors by identifying areas of need and establishing a coordinated evidence
 based multidisciplinary service to provide personalised, risk stratified long term follow up.

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06414343
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06414343 through Pure Global AI's free database. This phase not specified trial is sponsored by Royal Marsden NHS Foundation Trust and is currently Not yet recruiting. The study focuses on Melanoma. Target enrollment is 400 participants.

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