Squamous Cell Carcinoma of the Oral CavityINECOCNCT01636544
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
A study testing contralateral healthy tissue biopsy in people with Squamous Cell Carcinoma of the Oral Cavity and Leukoplakia Oral, run by Institut Pasteur at 1 site in France.
Trial summary
Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity, Leukoplakia Oral
- What is being tested?
- contralateral healthy tissue biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2012to 31 Jan 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years,
- For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
- For subgroup "OSCC" : histological diagnosis of OSCC,
- Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
- Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
- Informed consent signed.
Who cannot join
- Previous treatment of oral cancer,
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.
- Being tested
- contralateral healthy tissue biopsy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Leukokeratosis, Hereditary Mucosal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contralateral healthy tissue biopsyProcedure or surgery
At the time of surgery, a part of the specimen, plus a biopsy of the healthy (control) contralateral mucosa (i.e. right border of the tongue for a SCC of the left border, left cheek for a dysplasia of the right cheek and so on) will be harvested for research and immediately frozen at -80°C first in dry ice, then in a -80°C freezer.
| Study group | Role | What they receive |
|---|---|---|
| contralateral healthy tissue biopsy | Experimental | Not described Receives: Procedure: contralateral healthy tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
qPCR method
Measured: 30 months
Detection of others infectious agents
(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
Measured: 30 months
Secondary outcomes (1)
Clonality of viral agent
RMA and HTS
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study start15 Jun 2012
- Primary completion10 Dec 2015
- Study completion31 Jan 2016
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 Oral CavityStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chloé Bertolus, MD, Principal investigator, APHPAntoine Gessain, PhD, Study chair, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636544
- Sponsor's protocol ID
- 2011-45
- Acronym
- INECOC
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2012
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
- ClinicalTrials.gov ID
- NCT01636544
- Acronym / sponsor ID
- INECOC / 2011-45
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2012 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 10 Jul 2012 (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.
Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contralateral healthy tissue biopsy | Experimental | Procedure: contralateral healthy tissue biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 18 years,
- For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
- For subgroup "OSCC" : histological diagnosis of OSCC,
- Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
- Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
Key exclusion criteria (1 listed)
- Previous treatment of oral cancer,
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 |
|---|---|---|
| contralateral healthy tissue biopsyAt the time of surgery, a part of the specimen, plus a biopsy of the healthy (control) contralateral mucosa (i.e. right border of the tongue for a SCC of the left border, left cheek for a dysplasia of the right cheek and so on) will be harvested for research and immediately frozen at -80°C first in dry ice, then in a -80°C freezer. | Procedure or surgery | contralateral healthy tissue biopsy |
Primary outcome
Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method.
Time frame: 30 months
qPCR method
Detection of others infectious agents
Time frame: 30 months
(i) a high -density panviral resequencing microarray (RMA) and (ii) High-Throughput Sequencing (HTS)
1 secondary outcome
Clonality of viral agent
Time frame: 30 months
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 26 Apr 2022.
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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.
Chloé Bertolus, MD principal investigator
APHP
Antoine Gessain, PhD study chair
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contralateral healthy tissue biopsy in people with Squamous Cell Carcinoma of the Oral Cavity and Leukoplakia Oral, run by Institut Pasteur at 1 site in France.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Detection and characterization of HPV (human papillomavirus)by using qPCR (quantitative polymerase chain reaction) method. (time frame: 30 months). The study lists 2 primary outcomes in all. 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 26 Apr 2022.