Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07178847

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

Led by Centre Jean Perrin · Updated on 2026-06-03

59

Participants Needed

3

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating circulating DNA (cDNA) as a biomarker to detect residual disease after chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main goal is to determine if cDNA can identify remaining cancer three months after treatment by comparing cDNA detection with clinical and radiological responses. Participants will have blood samples taken 1 month and 3 months after completing chemoradiotherapy to measure cDNA levels. This study is an ancillary trial linked to the main Neck-TAR study and involves collecting 18 mL of blood at these two time points to monitor residual disease. During the study, participants will be evaluated through blood tests at the specified intervals. Researchers will assess the presence of cDNA and correlate it with objective response measures. Other outcomes include overall and progression-free survival, mutation profiles, and HPV genotypes. Participation involves follow-up visits for blood sampling and clinical assessments over several months after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient included in NeckTAR study
  • Written informed consent signed for NeckTAR-IN study
  • Affiliation to the French social security system
  • Aged 18 to 80 years
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 3 months after the end of chemoradiotherapy

Participants are monitored through blood samples collected to detect circulating DNA as a biomarker of residual disease after chemoradiotherapy.

2 visits (1 and 3 months after chemoradiotherapy)

Trial Site Locations

Total: 3 locations

1

Centre Jean PERRIN

Clermont-Ferrand, Puy-de-Dôme, France, 63011

Actively Recruiting

2

Hôpital de la Croix-Rousse

Lyon, France

Actively Recruiting

3

CHU de Saint-Étienne

Saint-Etienne, France

Actively Recruiting

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Research Team

A

Angeline GINZAC COUVÉ Project manager, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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