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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139020
Recruitment Status : Recruiting
First Posted : May 15, 2014
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Head and Neck Other: Plasma samples

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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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck
Study Start Date : February 2013
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
One EDTA tube is collected at the beginning of the study and there are only plasma samples at baseline, during treatment, and at progression.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139020


Contacts
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Contact: Jean-Pascal Machiels, MD, PhD 0032 2 764 ext 5457 jean-pascal.machiels@uclouvain.be
Contact: Matthias Papier, Msc Degree 0032 2 764 ext 47849 matthias.papier@uclouvain.be

Locations
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Belgium
Clinique Saint-Pierre Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Renaud Poncin, MD       Re.PONCIN@clinique-saint-pierre.be   
Contact: Dora Barrientos, Nurse         
Principal Investigator: Renaud Poncin, MD         
Grand Hôpital de Charleroi Recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Christophe Lonchay, MD       Christophe.Lonchay@ghdc.be;   
Contact: Janique Dewelle, Bio MSc         
Principal Investigator: Christophe Lonchay, MD         
Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize Recruiting
Haine-Saint-Paul, Belgium, 7100
Contact: Emmanuel Seront, MD, PhD       Emmanuel.Seront@jolimont.be   
Contact: Isabelle Buelens, Study Co         
Principal Investigator: Emmanuel Seront, MD, PhD         
Clinique et Maternité Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Stéphanie Henry, MD       Stephanie.HENRY@cmsenamur.be   
Contact: Monique Gilsoul, Study Co         
Principal Investigator: Stéphanie Henry, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02139020    
Other Study ID Numbers: UCL-ONCO 2013-01
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Targeted therapies
Plasma samples
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site