NCT05695222

Brief Summary

Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer, and one of the most common cancers worldwide. The majority of CSCCs are easily removed by surgery and have excellent prognosis. However, a small subset has poor outcomes, including secondary spread in the body (metastasis) and death. The investigators will look at existing CSCC in people from two UK dermatology centres. The investigators will then evaluate the accuracy of current staging systems in predicting risk of poor outcomes in people. The investigators hope that this project will improve the management of patients with CSCC by validating the predictive power of currently available histological staging classifications for cSCC. In the second stage of the study, The investigators will see whether better prediction tools can be found.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2023Jun 2028

First Submitted

Initial submission to the registry

December 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2028

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

December 22, 2022

Last Update Submit

April 1, 2026

Conditions

Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence or metastasis

    Proportion of patients developing cutaneous squamous cell carcinoma locoregional recurrence, nodal or distant metastases

    4 years

Interventions

This is not an interventional studyOTHER

This is not an interventional study

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated at two tertiary Dermatology centers

You may qualify if:

  • Over 18 years old with diagnosis of CSCC

You may not qualify if:

  • Patients who decline for their data to be used for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Whipps Cross University Hospital

London, E11 1NR, United Kingdom

RECRUITING

Dr Emilia Peleva

London, United Kingdom

ACTIVE NOT RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 23, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

June 5, 2028

Study Completion (Estimated)

June 5, 2028

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)