Squamous Cell Carcinoma of the Oral CavityMARGINSNCT05934929
Contribution of Residual Tumour DNA Testing on the Surgical Bed
A study testing Circulating tumor DNA detection in people with Squamous Cell Carcinoma of the Oral Cavity, run by Centre Henri Becquerel at 2 sites in France.
Trial summary
The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision. 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
- What is being tested?
- Circulating tumor DNA detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jan 2024to 29 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Signed informed consent
- Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
- 18 years of age or older
- Member or beneficiary of a social security scheme.
Who cannot join
- Absence of signed informed consent
- Patient of protected age
- Psychosocial problems
- Not affiliated to or benefiting from a social security scheme
- Previous cervical irradiation
- Pregnant or breast-feeding women
- Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity
The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.
Read the detailed description
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.
Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
- Being tested
- Circulating tumor DNA detection
- Keywords
- oral cavity, squamous cell carcinoma, residual tumor DNA, head and neck surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor DNA detectionOther
biological assessment on operating bed to detect residual circulating tumor DNA
| Study group | Role | What they receive |
|---|---|---|
| circulating tumor DNA detection on operating bed | Experimental | biological assessment on operating bed to detect residual circulating tumor DNA Receives: Other: Circulating tumor DNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual tumro DNA on operating bed
Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors
Measured: during the surgery
Secondary outcomes (1)
Survival without locoregional recurrence rate
Proportion of patients with circulating tumour DNA and in the cervical lymphatic drainage fluid or circulating blood according to the presence or absence of residual tumour DNA on the operating bed
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start8 Jan 2024
- Primary completion22 Dec 2025
- Study completion29 Dec 2027 (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 Oral CavityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise-Marie Roussel, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934929
- Sponsor's protocol ID
- CHB23.01
- Other IDs
- 2023-A00567-38
- Acronym
- MARGINS
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity
- ClinicalTrials.gov ID
- NCT05934929
- Acronym / sponsor ID
- MARGINS / CHB23.01
- Keywords
- oral cavity, squamous cell carcinoma, residual tumor DNA, head and neck surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 7 Jul 2023 (actual)
- 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 aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.
Detailed description
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.
Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| circulating tumor DNA detection on operating bed | Experimental | Other: Circulating tumor DNA detectionbiological assessment on operating bed to detect residual circulating tumor DNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
- 18 years of age or older
- Member or beneficiary of a social security scheme.
Key exclusion criteria (7 listed)
- Absence of signed informed consent
- Patient of protected age
- Psychosocial problems
- Not affiliated to or benefiting from a social security scheme
- Previous cervical irradiation
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 |
|---|---|---|
| Circulating tumor DNA detectionbiological assessment on operating bed to detect residual circulating tumor DNA | Other | circulating tumor DNA detection on operating bed |
Primary outcome
Residual tumro DNA on operating bed
Time frame: during the surgery
Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors
1 secondary outcome
Survival without locoregional recurrence rate
Time frame: 24 months
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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Lise-Marie Roussel, MD principal investigator
Centre Henri Becquerel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating tumor DNA detection in people with Squamous Cell Carcinoma of the Oral Cavity, run by Centre Henri Becquerel at 2 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?
The sponsor lists 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
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?
Residual tumro DNA on operating bed (time frame: during the surgery). 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 2 Jan 2026.