Locally Advanced Head and Neck CarcinomaNeckTAR-INNCT07178847
cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas
A study testing blood sampling in people with Locally Advanced Head and Neck Carcinoma, run by Centre Jean Perrin at 4 sites in France.
Trial summary
The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Head and Neck Carcinoma
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Oct 2025to Jul 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Selection Criteria:
- Patient included in NeckTAR study
- Written informed consent signed for NeckTAR-IN study
- Affiliation to the French social security system
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Angeline GINZAC COUVÉ Project manager, PhD contact
France4 sites, 4 recruiting
- Recruiting
CH Henri Mondor Aurillac
Aurillac, CANTAL, 15000
Daniela BURLACU, Dr, 0471465613, d.burlacu@ch-aurillac.fr
- Recruiting
Centre Jean PERRIN
Clermont-Ferrand, Puy-de-Dôme, 63011
Angeline GINZAC Project manager, PhD, 0463663337 ext. +33, angeline.ginzac@clermont.unicancer.fr
Maureen BERNADACH Coordinator, MD
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Philippe CÉRUSE, Pr
- Recruiting
CHU de Saint-Étienne
Saint-Etienne
Yann LELONGE, Dr
About this study
Official title: Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma
The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.
The main question it aims to answer is :
- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).
Participants will :
- be included in the main study (Neck-TAR)
- have a blood sample 1 and 3-month after the end of treatment
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Being tested
- blood sampling
- Keywords
- circulating DNA, residual disease
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| cDNA detection | Experimental | Not described Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cDNA detection and objective response 3 months after the end of chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
Measured: 3 months after chemoradiotherapy
Secondary outcomes (6)
cDNA detection and objective response one month after the end of chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
Measured: 1 month after the end of chemoradiotherapy
Overall survival
The overall survival is defined as the time between the date of inclusion and the date of death from any cause.
Measured: At the end of the main study (27 months after the end of treatment)
Progression-free survival
The progression-free survival is defined as the time between the date of inclusion and the date of the first progression of the disease (clinical or radiological) or death from any cause.
Measured: At the end of the main study (27 months after the end of treatment)
cDNA kinetic
cDNA detection at 1 and 3 months after the end of chemoradiotherapy
Measured: 1- and 3-month after the end of chemoradiotherapy
Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA
This will be evaluated according to the mutational profile determined by NGS at each timepoint
Measured: 1- and 3-months after the end of chemoradiotherapy
Determining the most frequent mutations.
That will be evaluated by analysing the results of NGS (among the 194 genes in our panel)
Measured: 3-months after the end of chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start13 Oct 2025
- Primary completionApr 2029 (estimated)
- Study completionJul 2031 (estimated)
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 Locally Advanced Head and Neck CarcinomaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients will have a blood sample collected one month after the end of chemoradiotherapy and another at three months (excepted if already done in the main study NeckTAR, e.g., if patient have residual disease and an indication for salvage adenectomy).
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maureen BERNADACH Coordinator, MD, Study director, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178847
- Sponsor's protocol ID
- 2025-A01108-41
- Acronym
- NeckTAR-IN
- Status last verified
- Jul 2026
- First submitted
- 3 Sep 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed in the current study are available from the corresponding author on reasonable request.
Publications
Ginzac A, Ventelou L, Ferreira MC, Canetti L, Biau J, Molnar I, Ponelle-Chachuat F, Philippe S, Saroul N, Pham-Dang N, Durando X, Bernadach M. Prospective multicentre study evaluating ctDNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carcinoma: NeckTAR-IN protocol. BMJ Open. 2026 Aug 7;16(8):e118532. doi: 10.1136/bmjopen-2026-118532.
PubMed 42567634
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07178847
- Acronym / sponsor ID
- NeckTAR-IN / 2025-A01108-41
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Keywords
- circulating DNA, residual disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 17 Sep 2025 (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 goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.
The main question it aims to answer is :
- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).
Participants will :
- be included in the main study (Neck-TAR)
- have a blood sample 1 and 3-month after the end of treatment
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients will have a blood sample collected one month after the end of chemoradiotherapy and another at three months (excepted if already done in the main study NeckTAR, e.g., if patient have residual disease and an indication for salvage adenectomy).
| Arm | Type | Receives |
|---|---|---|
| cDNA detection | Experimental | Biological: blood sampling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| blood samplingThe intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy | Biological | cDNA detection |
Primary outcome
cDNA detection and objective response 3 months after the end of chemoradiotherapy
Time frame: 3 months after chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
6 secondary outcomes
cDNA detection and objective response one month after the end of chemoradiotherapy
Time frame: 1 month after the end of chemoradiotherapy
Overall survival
Time frame: At the end of the main study (27 months after the end of treatment)
Progression-free survival
Time frame: At the end of the main study (27 months after the end of treatment)
cDNA kinetic
Time frame: 1- and 3-month after the end of chemoradiotherapy
Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA
Time frame: 1- and 3-months after the end of chemoradiotherapy
Determining the most frequent mutations.
Time frame: 3-months after the end of chemoradiotherapy
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 Sep 2026.
- Background: PubMed 42567634Ginzac A, Ventelou L, Ferreira MC, Canetti L, Biau J, Molnar I, Ponelle-Chachuat F, Philippe S, Saroul N, Pham-Dang N, Durando X, Bernadach M. Prospective multicentre study evaluating ctDNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carcinoma: NeckTAR-IN protocol. BMJ Open. 2026 Aug 7;16(8):e118532. doi: 10.1136/bmjopen-2026-118532.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed in the current study are available from the corresponding author on reasonable request.
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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.
Angeline GINZAC COUVÉ Project manager, PhD contact
Maureen BERNADACH Coordinator, MD study director
Centre Jean Perrin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Locally Advanced Head and Neck Carcinoma, run by Centre Jean Perrin at 4 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: looking for participants now, as of the sponsor's last update on 11 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 4 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?
Contact Angeline GINZAC COUVÉ Project manager, PhD (0463663337 ext. +33, angeline.ginzac@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cDNA detection and objective response 3 months after the end of chemoradiotherapy (time frame: 3 months after chemoradiotherapy). 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 NCT07178847, 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 2026.