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

NCT07178847 | Recruiting

• 1 other identifier: 2025-A01108-41
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Locally Advanced Head and Neck Carcinoma

Keywords

circulating DNA; residual disease

Outcome Measures

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)

  3 months after chemoradiotherapy

Secondary Outcomes (6)

• cDNA detection and objective response one month after the end of chemoradiotherapy

  1 month after the end of chemoradiotherapy

• Overall survival

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

• Progression-free survival

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

• cDNA kinetic

  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

  1- and 3-months after the end of chemoradiotherapy

Study Arms (1)

cDNA detection

EXPERIMENTAL

Biological: blood sampling

Interventions

blood sampling BIOLOGICAL

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

cDNA detection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Selection Criteria: * Patient included in NeckTAR study * Written informed consent signed for NeckTAR-IN study * Affiliation to the French social security system

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (3)

Centre Jean PERRIN

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

RECRUITING

Hôpital de la Croix-Rousse

Lyon, France

RECRUITING

CHU de Saint-Étienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maureen BERNADACH Coordinator, MD

  Centre Jean Perrin

  STUDY DIRECTOR

Central Study Contacts

Angeline GINZAC COUVÉ Project manager, PhD

CONTACT

0463663337; angeline.ginzac@clermont.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 17, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): July 1, 2031
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (3)