Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients
Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck
1 other identifier
observational
400
1 country
5
Brief Summary
The investigators will collect plasma samples at baseline, during treatment, and at progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2033
December 11, 2023
December 1, 2023
19.9 years
May 13, 2014
December 8, 2023
Conditions
Keywords
Outcome Measures
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
one year after the collection
Study Arms (1)
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
Interventions
Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations
Eligibility Criteria
PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
You may qualify if:
- 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
You may not qualify if:
- patients with another type of head and neck cancer
- patients non treated with targeted therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Clinique Saint-Pierre
Ottignies, Brabant Wallon, 1340, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6000, Belgium
Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
Haine-Saint-Paul, 7100, Belgium
CHU Liège
Liège, 4000, Belgium
Clinique et Maternité Sainte-Elisabeth
Namur, 5000, Belgium
Biospecimen
One EDTA tube is collected at the beginning of the study and there are only plasma samples at baseline, during treatment, and at progression.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Pascal Machiels, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
February 1, 2013
Primary Completion (Estimated)
January 1, 2033
Study Completion (Estimated)
January 1, 2033
Last Updated
December 11, 2023
Record last verified: 2023-12