Cutaneous Squamous Cell Carcinoma Staging Study

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05695222
• Collaborator: (none)
• Enrollment: 1,500
• Anticipated Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Squamous Cell Carcinoma	Other: This is not an interventional study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Comparison of the Prognostic Capacity of Existing Staging Systems for Cutaneous Squamous Cell Carcinoma
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Outcome Measures

Primary Outcome Measures

1. Recurrence or metastasis [4 years]

   Cutaneous squamous cell carcinoma locoregional recurrence, nodal or distant metastases

2. Metastasis [4 years]

   Cutaneous squamous cell carcinoma nodal or distant metastases

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Over 18 years old with diagnosis of CSCC

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Queen Mary University of London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT05695222
• Other Study ID Numbers: 291683
• First Posted: Jan 23, 2023
• Last Update Posted: Jan 23, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell

Study Results

No Results Posted as of Jan 23, 2023