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RecruitingNCT07178847NeckTAR-INUpdated Sep 11, 2026

cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas

An interventional study of blood sampling in Locally Advanced Head and Neck Carcinoma, sponsored by Centre Jean Perrin. Recruiting at 4 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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
02

Conditions studied

  • Locally Advanced Head and Neck Carcinoma

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Keywords

  • circulating DNA
  • residual disease
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Selection Criteria:

  • Patient included in NeckTAR study
  • Written informed consent signed for NeckTAR-IN study
  • Affiliation to the French social security system
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (estimated)

Study arms

  • Experimental
    cDNA detection

    Biological: blood sampling

Interventions

  • Biologicalblood sampling

    The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months after chemoradiotherapy

Secondary outcomes

  1. 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)

    Time frame: 1 month after the end of chemoradiotherapy

  2. Overall survival

    The overall survival is defined as the time between the date of inclusion and the date of death from any cause.

    Time frame: At the end of the main study (27 months after the end of treatment)

  3. 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.

    Time frame: At the end of the main study (27 months after the end of treatment)

  4. cDNA kinetic

    cDNA detection at 1 and 3 months after the end of chemoradiotherapy

    Time frame: 1- and 3-month after the end of chemoradiotherapy

  5. 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

    Time frame: 1- and 3-months after the end of chemoradiotherapy

  6. Determining the most frequent mutations.

    That will be evaluated by analysing the results of NGS (among the 194 genes in our panel)

    Time frame: 3-months after the end of chemoradiotherapy

06

Study locations

4 of 4 sites recruiting
  • CH Henri Mondor Aurillac
    Aurillac, CANTAL 15000, France
    Recruiting
  • Centre Jean PERRIN
    Clermont-Ferrand, Puy-de-Dôme 63011, France
    Recruiting
  • Hôpital de la Croix-Rousse
    Lyon, France
    • Philippe CÉRUSE, Pr · Principal investigator
    Recruiting
  • CHU de Saint-Étienne
    Saint-Etienne, France
    • Yann LELONGE, Dr · Principal investigator
    Recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: Yes — The datasets used and/or analysed in the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol, Icf, Csr

08

Registry details

Key details

Study ID
NCT07178847
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Sep 17, 2025
Start date
Oct 13, 2025
Primary completion
Apr 2029 (estimated)
Completion
Jul 2031 (estimated)
Last update
Sep 11, 2026

Study contacts

Angeline GINZAC COUVÉ Project manager, PhD
Contact
angeline.ginzac@clermont.unicancer.fr
0463663337 ext. +33
Maureen BERNADACH Coordinator, MD
study director · Centre Jean Perrin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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