Head and Neck CancerCARIONCT00963326
Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer
An observational study of Head and Neck Cancer, run by Centre Oscar Lambret at 9 sites in France.
Trial summary
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 15 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 30 participants
- Where
- 9 sitesFrance
- Study dates
- 4 Mar 2009to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed squamous cell carcinoma of the larynx, pharynx, or oral cavity without risk factors
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the larynx, pharynx, or oral cavity
- No risk factors of alcohol consumption, smoking, or occupational hazards such as asbestos, hydrocarbons, paints, nickel, stone dust, or wood dust.
- Must be a life-time non-smoker, not a former smoker
- Measurable disease by RECIST criteria
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- No other serious concomitant medical conditions precluding general anesthesia
- No psychological, familial, social, or geographical reasons that would preclude follow up
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Amiens
Amiens
CHU de Caen
Caen, 14033
Centre François Baclesse
Caen, 14076
Centre Oscar Lambret
Lille, 59020
CHRU de Lille
Lille, 59037
Hôpital de la Timone
Marseille, 13385
Centre Antoine Lacassagne
Nice
CHU de Nîmes
Nîmes, 30029
CHU de Rouen
Rouen, 76031
About this study
Official title: Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.
Read the detailed description
OBJECTIVES:
Primary
- Characterize, morphologically and molecularly, squamous cell carcinoma of the larynx, pharynx, or oral cavity in patients without high-risk factors, such as alcohol consumption, smoking, or occupation.
Secondary
- Study the impact parameters of morphology, molecular characteristics, and genomics on disease-free survival and overall survival of these patients.
- Study the impact parameters of morphological, molecular, and genomic control in the tumor.
- Assess, in advanced tumors, the risk of heterogeneity of morphological, molecular, and genomic control in the tumor.
OUTLINE: This is a multicenter study.
Blood, tumor tissue, and healthy tissue samples are collected before treatment begins.
Patients are followed up every 3 months for 2 years (additional biopsies may be collected).
- Conditions
- Head and Neck Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate by RECIST criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study start4 Mar 2009
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Lefebvre, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963326
- Sponsor's protocol ID
- CARIO-0711
- Other IDs
- CARIO-0711, 2007-11, RECF0897, 2008-A00300-55
- Acronym
- CARIO
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2009
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation
- ClinicalTrials.gov ID
- NCT00963326
- Acronym / sponsor ID
- CARIO / CARIO-0711
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 4 Mar 2009 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Aug 2009 (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.
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.
Detailed description
OBJECTIVES:
Primary
- Characterize, morphologically and molecularly, squamous cell carcinoma of the larynx, pharynx, or oral cavity in patients without high-risk factors, such as alcohol consumption, smoking, or occupation.
Secondary
- Study the impact parameters of morphology, molecular characteristics, and genomics on disease-free survival and overall survival of these patients.
- Study the impact parameters of morphological, molecular, and genomic control in the tumor.
- Assess, in advanced tumors, the risk of heterogeneity of morphological, molecular, and genomic control in the tumor.
OUTLINE: This is a multicenter study.
Blood, tumor tissue, and healthy tissue samples are collected before treatment begins.
Patients are followed up every 3 months for 2 years (additional biopsies may be collected).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed squamous cell carcinoma of the larynx, pharynx, or oral cavity without risk factors
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
Primary outcome
Tumor response rate by RECIST criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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. This study is not recruiting at the moment.
Jean-Louis Lefebvre, MD principal investigator
Centre Oscar Lambret
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Centre Oscar Lambret at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate by RECIST criteria. 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 17 Sep 2026.