cN0 Oral Squamous Cell CarcinomasOSNA-ORLNCT02852343
One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma
An observational study of cN0 Oral Squamous Cell Carcinomas, run by Rennes University Hospital at 1 site in France.
Trial summary
The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cN0 Oral Squamous Cell Carcinomas
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2015to 21 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with sceduled procedure to cN0 oral squamous cell carcinomas
Who may be able to join
- Patient > 18 years old
- Head and neck squamous cell carcinoma diagnosed by biopsy
- N0 classification (N0: no lymph node invasion on clinical and radiological examination).
- Neck dissection or sentinel lymph node biopsy required to treat the patient
- ECOG 1,2 or 3
- Patient's consent
Who cannot join
- Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
- Contraindication or patient unwillingness to undergo surgical treatment
- Incapacitated adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS
The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).
- Conditions
- cN0 Oral Squamous Cell Carcinomas
What is being measured
The primary outcome is the main question the study is designed to answer.
number of CK19 mRNA copies/µL of diluted lymph node lysate
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start5 Jan 2015
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for cN0 Oral Squamous Cell CarcinomasStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852343
- Sponsor's protocol ID
- 35RC14_9878
- Acronym
- OSNA-ORL
- Status last verified
- Sep 2018
- First submitted
- 19 Jul 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
Publications
Peigne L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jegoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.
PubMed 32004908
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS
- ClinicalTrials.gov ID
- NCT02852343
- Acronym / sponsor ID
- OSNA-ORL / 35RC14_9878
- Conditions
- cN0 Oral Squamous Cell Carcinomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 2 Aug 2016 (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 main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with sceduled procedure to cN0 oral squamous cell carcinomas
Key inclusion criteria (6 listed)
- Patient > 18 years old
- Head and neck squamous cell carcinoma diagnosed by biopsy
- N0 classification (N0: no lymph node invasion on clinical and radiological examination).
- Neck dissection or sentinel lymph node biopsy required to treat the patient
- ECOG 1,2 or 3
Key exclusion criteria (3 listed)
- Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
- Contraindication or patient unwillingness to undergo surgical treatment
- Incapacitated adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of CK19 mRNA copies/µL of diluted lymph node lysate
Time frame: through study completion, an average of 1 year
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 11 Sep 2018.
- Derived from this study: PubMed 32004908Peigne L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jegoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.
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Oral Squamous Cell Carcinoma (OSCC)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of cN0 Oral Squamous Cell Carcinomas, run by Rennes University Hospital 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 3 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 11 Sep 2018. 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?
number of CK19 mRNA copies/µL of diluted lymph node lysate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852343, which also lists 1 linked publication.
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 Sep 2018.