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Recruiting NCT07178847

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

No phase Interventional Locally Advanced Head and Neck Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sampling.
Who it may be relevant to
Registry conditions: Locally Advanced Head and Neck Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma

Overview

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

Interventions

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

Primary outcome measures

  • cDNA detection and objective response 3 months after the end of chemoradiotherapy [Time frame: 3 months after chemoradiotherapy]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Selection Criteria:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 4 centers
  • CH Henri Mondor Aurillac — Aurillac
  • Centre Jean PERRIN — Clermont-Ferrand
  • Hôpital de la Croix-Rousse — Lyon
  • CHU de Saint-Étienne — Saint-Etienne

Identifiers

NCT: NCT07178847 · 2025-A01108-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗