Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients

Recruiting

• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Other: Plasma samples

• Registration Number: NCT02139020
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The investigators will collect plasma samples at baseline, during treatment, and at progression.

Detailed Description

In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2033-01
• Study Completion: 2033-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients treated with radiation therapy and cetuximab according to Bonner et al
• patients treated with cetuximab in combination with chemotherapy according to Vermorken et al.
• patients treated with a molecular targeted agent as a part of a clinical study

Exclusion Criteria

• patients with another type of head and neck cancer
• patients non treated with targeted therapies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	Plasma samples	Patients with squamous cell carcinoma of the head and neck, targeted therapies, plasma samples: * Group 1 = patients treated with radiation therapy and cetuximab according to Bonner et al \[11\] * Group 2 = patients treated with cetuximab in combination with chemotherapy according to Vermorken et al. \[10\] * Group 3 = patients treated with a molecular targeted agent as a part of a clinical study

Primary Outcome Measures

Name	Time	Method
Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents	one year after the collection	All the analyses will be done when we have enough of collected samples

Trial Locations

Locations (5)

Clinique Saint-Pierre; 🇧🇪 Ottignies, Brabant Wallon, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Hainaut, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize; 🇧🇪 Haine-Saint-Paul, Belgium

Clinique et Maternité Sainte-Elisabeth; 🇧🇪 Namur, Belgium