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

December 8, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Haine-Saint-Paul, Belgium, 7100
        • Recruiting
        • Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
        • Contact:
        • Contact:
          • Isabelle Buelens, Study Co
        • Principal Investigator:
          • Emmanuel Seront, MD, PhD
      • Liège, Belgium, 4000
      • Namur, Belgium, 5000
        • Recruiting
        • Clinique et Maternité Sainte-Elisabeth
        • Principal Investigator:
          • Stephanie Henry, MD
        • Contact:
        • Contact:
          • Monique Gilsoul, Study Co
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Recruiting
        • Clinique Saint-PIerre
        • Contact:
        • Contact:
          • Dora Barrientos, Nurse
        • Principal Investigator:
          • Renaud Poncin, MD
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Recruiting
        • Grand Hôpital de Charleroi
        • Contact:
        • Contact:
          • Janique Dewelle, Bio MSc
        • Principal Investigator:
          • Christophe Lonchay, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment

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
Other: Plasma samples
Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Jean-Pascal Machiels, MD, PhD, Cliniques universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimated)

May 15, 2014

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL-ONCO 2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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