Back to resultsContribution of Residual Tumour DNA Testing on the Surgical Bed (MARGINS)
Primary Purpose
Squamous Cell Carcinoma of the Oral Cavity
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Circulating tumor DNA detection
Sponsored by
About this trial
This is an interventional other trial for Squamous Cell Carcinoma of the Oral Cavity focused on measuring oral cavity, squamous cell carcinoma, residual tumor DNA, head and neck surgery
Eligibility Criteria
Inclusion Criteria: Signed informed consent Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable 18 years of age or older Member or beneficiary of a social security scheme. Exclusion Criteria: 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.).
Sites / Locations
- CHU Rouen
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
circulating tumor DNA detection on operating bed
Arm Description
biological assessment on operating bed to detect residual circulating tumor DNA
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Survival without locoregional recurrence rate
Proportion of patients with circulating tumour DNA and in the cervical lymphatic drainage fluid or circulating blood according to the presence or absence of residual tumour DNA on the operating bed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05934929
Brief Title
Contribution of Residual Tumour DNA Testing on the Surgical Bed
Acronym
MARGINS
Official Title
Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.
Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oral Cavity
Keywords
oral cavity, squamous cell carcinoma, residual tumor DNA, head and neck surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
circulating tumor DNA detection on operating bed
Arm Type
Experimental
Arm Description
biological assessment on operating bed to detect residual circulating tumor DNA
Intervention Type
Other
Intervention Name(s)
Circulating tumor DNA detection
Intervention Description
biological assessment on operating bed to detect residual circulating tumor DNA
Primary Outcome Measure Information:
Title
Residual tumro DNA on operating bed
Description
Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
Survival without locoregional recurrence rate
Description
Proportion of patients with circulating tumour DNA and in the cervical lymphatic drainage fluid or circulating blood according to the presence or absence of residual tumour DNA on the operating bed
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
18 years of age or older
Member or beneficiary of a social security scheme.
Exclusion Criteria:
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise-Marie Roussel, MD
Phone
+33232082985
Email
lise-marie.roussel@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise-Marie Roussel, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Deneuve, Md
Email
sophie.deneuve@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Sophie Deneuve, Md
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise-Marie Roussel, MD
Phone
+33232082985
Email
lise-marie.roussel@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Lise-Marie Roussel, Md
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contribution of Residual Tumour DNA Testing on the Surgical Bed
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