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RecruitingNCT02139020Updated Dec 11, 2023

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

An observational study in Squamous Cell Carcinoma of the Head and Neck, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 5 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

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Conditions studied

  • Squamous Cell Carcinoma of the Head and Neck

Keywords

  • Targeted therapies
  • Plasma samples
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 400 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • patients with another type of head and neck cancer
  • patients non treated with targeted therapies
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherPlasma samples

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

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What researchers measure

Primary outcomes

  1. Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents

    All the analyses will be done when we have enough of collected samples

    Time frame: one year after the collection

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Study locations

5 of 5 sites recruiting
  • Clinique Saint-Pierre
    Ottignies, Brabant Wallon 1340, Belgium
    Recruiting
  • Grand Hôpital de Charleroi
    Charleroi, Hainaut 6000, Belgium
    • Christophe Lonchay, MD · Contact · Christophe.Lonchay@ghdc.be;
    • Janique Dewelle, Bio MSc · Contact
    • Christophe Lonchay, MD · Principal investigator
    Recruiting
  • Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
    Haine-Saint-Paul, 7100, Belgium
    • Emmanuel Seront, MD, PhD · Contact · Emmanuel.Seront@jolimont.be
    • Isabelle Buelens, Study Co · Contact
    • Emmanuel Seront, MD, PhD · Principal investigator
    Recruiting
  • CHU Liège
    Liège, 4000, Belgium
    Recruiting
  • Clinique et Maternité Sainte-Elisabeth
    Namur, 5000, Belgium
    • Stéphanie Henry, MD · Contact · Stephanie.HENRY@cmsenamur.be
    • Monique Gilsoul, Study Co · Contact
    • Stéphanie Henry, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02139020
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
May 15, 2014
Start date
Feb 2013
Primary completion
Jan 2033 (estimated)
Completion
Jan 2033 (estimated)
Last update
Dec 11, 2023

Study contacts

Jean-Pascal Machiels, MD, PhD
Contact
jean-pascal.machiels@uclouvain.be
0032 2 764 ext. 5457
Séverine Carlier, MD
Contact
severine.carlier@uclouvain.be
0032 2 764 ext. 47849
Jean-Pascal Machiels, MD, PhD
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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