Squamous Cell Carcinoma of the Head and NeckNCT02139020
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 5 sites in Belgium.
Trial summary
The investigators will collect plasma samples at baseline, during treatment, and at progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Plasma samples
- How many people
- 400 participants
- Where
- 5 sitesBelgium
- Study dates
- Feb 2013to Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Who may be able to join
- 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
Who cannot join
- patients with another type of head and neck cancer
- patients non treated with targeted therapies
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6000
Christophe Lonchay, MD, Christophe.Lonchay@ghdc.be;
Janique Dewelle, Bio MSc
- Recruiting
Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
Haine-Saint-Paul, 7100
Emmanuel Seront, MD, PhD, Emmanuel.Seront@jolimont.be
Isabelle Buelens, Study Co
- Recruiting
CHU Liège
Liège, 4000
Maude Piron, PhD, brieuc.sautois@chuliege.be
Brieu Sautois
- Recruiting
Clinique et Maternité Sainte-Elisabeth
Namur, 5000
Stéphanie Henry, MD, Stephanie.HENRY@cmsenamur.be
Monique Gilsoul, Study Co
- Recruiting
Clinique Saint-Pierre
Ottignies, Brabant Wallon, 1340
Renaud Poncin, MD, Re.PONCIN@clinique-saint-pierre.be
Dora Barrientos, Nurse
About this study
Official title: 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.
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
- Being tested
- Plasma samples
- Keywords
- Targeted therapies, Plasma samples
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma samplesOther
Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Plasma samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year after the collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal Machiels, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139020
- Sponsor's protocol ID
- UCL-ONCO 2013-01
- Status last verified
- Dec 2023
- First submitted
- 13 May 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02139020
- Acronym / sponsor ID
- UCL-ONCO 2013-01
- Keywords
- Targeted therapies, Plasma samples
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: Plasma samplesPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients with another type of head and neck cancer
- patients non treated with targeted therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma samplesPlasma samples at baseline (and one whole blood sample) and at every radiological evaluations | Other | No treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Pascal Machiels, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pascal Machiels, MD, PhD (0032 2 764 ext. 5457, jean-pascal.machiels@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents (time frame: one year after the collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.