Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC

NCT05741073 | Recruiting

• 1 other identifier: Euro-NMSC
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC/BCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.

Conditions

Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Real-world demographics in routine clinical practice

  To capture real-world demographics in routine clinical practice, independent of treatment used across different European regions in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC.

  min. 2 years up to max 5 years of observation

Secondary Outcomes (15)

• Tumor characteristics

  min. 2 years up to max 5 years of observation

• Treatment patterns

  min. 2 years up to max 5 years of observation

• Overall survival

  min. 2 years up to max 5 years of observation

• Adverse drug reactions

  min. 2 years up to max 5 years of observation

• Treatment discontinuation

  min. 2 years up to max 5 years of observation

Study Arms (3)

resected HR-cSCC

Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting

advanced cSCC

Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2)

advanced BCC

Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with documentation of advanced diagnosis of cSCC/ BCC or with HR-cSCC since AUG 2019 and who fulfill the inclusion and exclusion criteria described below will be included in this registry. Enrollment into all 3 cohorts will be performed concurrently. All patients will be treated according to specifications stated in the respective local/European guidelines of the drugs administered in clinical routine.

You may qualify if:

• Patients aged ≥18 years at index date
• Patients documented in the European NMSC-registry fulfilling EMR quality standard
• Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)

You may not qualify if:

• \. Patients receiving treatment within a clinical trial.

Sponsors & Collaborators

• EuMelaReg gGmbH: lead

Study Sites (1)

UZ (Universitair Ziekenhuis) Brüssel

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Central Study Contacts

Alexandra Hansen

CONTACT

+493037026901; alexandra.hansen@eumelareg.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)