Contribution of Residual Tumour DNA Testing on the Surgical Bed

NCT05934929 | Active Not Recruiting

• 2 other identifiers: CHB23.012023-A00567-38
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Keywords

oral cavity; squamous cell carcinoma; residual tumor DNA; head and neck surgery

Outcome Measures

Primary Outcomes (1)

• Residual tumro DNA on operating bed

  Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors

  during the surgery

Secondary Outcomes (1)

• Survival without locoregional recurrence rate

  24 months

Study Arms (1)

circulating tumor DNA detection on operating bed

EXPERIMENTAL

biological assessment on operating bed to detect residual circulating tumor DNA

Other: Circulating tumor DNA detection

Interventions

Circulating tumor DNA detection OTHER

biological assessment on operating bed to detect residual circulating tumor DNA

circulating tumor DNA detection on operating bed

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
• years of age or older
• Member or beneficiary of a social security scheme.

You may not qualify if:

• Absence of signed informed consent
• Patient of protected age
• Psychosocial problems
• Not affiliated to or benefiting from a social security scheme
• Previous cervical irradiation
• Pregnant or breast-feeding women
• Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

CHU Rouen

Rouen, 76000, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Lise-Marie Roussel, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: January 8, 2024
• Primary Completion: December 22, 2025
• Study Completion (Estimated): December 29, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)