SerUM markers in MERkel Cell Carcinoma patients: a longitudinal moniTorIng study for optiMization of European guidelines.

Recruiting

• Conditions: neuroendocrine carcinoma; trabecular carcinoma; 10040900

• Registration Number: NL-OMON53695
• Lead Sponsor: niversity Hospital Center of Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1) Patients with a « de novo » diagnosis of MCC, confirmed on
histological criteria (neuroendocrine morphology, CK20 staining
and/or neuroendocrine and/or SATB2 staining, exclusion of
differential diagnosis)
2) >= 18 years of age
3) Written informed consent obtained from the participant

Exclusion Criteria

1) Patients following any measures of legal presentation
2) Pregnancy or breastfeeding

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MCC recurrence (either local, nodal or distant metastases after baseline,<br /><br>assessed by radiological and/or histological assessment) at any time of follow<br /><br>up. Diagnostic performances (specificity, sensitivity, positive and negative<br /><br>predictive values) for disease recurrence will be assessed for each blood<br /><br>biomarker (increase in T-Ag antibodies and miR375 levels).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>MCC progression after baseline, assessed by radiological assessment (RECIST<br /><br>criteria), at any time of follow up. Diagnostic performances (specificity,<br /><br>sensitivity, positive and negative predictive values) for disease progression<br /><br>will be assessed for each blood biomarker (increase in T-Ag antibodies and<br /><br>miR375 levels). Recurrence-free survival, Overall survival, Disease specific<br /><br>survival according to clinical factors (age, AJCC stage, MCPyV status and<br /><br>immune suppression) and biomarkers at baseline (T-Ag antibodies and miR375<br /><br>levels) will be determined.</p><br>