Residual Disease Evaluation of Resected NSCLC by cirDNA Analysis

NCT05165160 | Active Not Recruiting

• 1 other identifier: RECHMPL20_0548
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Prognosis of resectable early stages NSCLC might be improved by a better knowledge of post-operative minimal residual disease (MRD). This could be achieved by studying patient with stage I to IIIA completely resected-NSCLC, comparing qualitative and quantitative features of pre- and post-operative circulating cell-free DNA (cirDNA), using MiTest. We assume that the evolution of the parameters of MiTest and relapse rate after surgery are related and expect to prove that normalization of MiTest at one month after surgery is a prognostic factor of reduced relapse at one year.

Conditions

Nsclc

Keywords

Stage I to IIIA; Performance status 0-2; Written and signed informed consent form

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival probability according to MiTest at one year after surgery (RFS1)

  The year after surgery

Study Arms (1)

Eligible patients

EXPERIMENTAL

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Pre- and postoperative blood sample

Eligible patients

Eligibility Criteria

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

You may qualify if:

• Age: 18 years or older
• Patients with a resectable NSCLC
• Definite stage I to IIIA
• Performance status of 0, 1 or 2
• Normal end organ functions
• Written and signed informed consent form
• Subjects must be covered by public health insurance.

You may not qualify if:

• Any previous systemic neoadjuvant treatment: targeted therapy, chemotherapy, immune checkpoint blockade
• Previous radiotherapeutic neoadjuvant treatment
• Resection margins R1 and R2
• Non-invasive lung carcinoma
• Multiple primary lung cancer.
• Previous malignancy during the past 3 years (except non-melanomatous skin cancer)
• Preexisting interstitial lung disease
• known HIV, active viral B hepatitis or C hepatitis
• Patient with any other situation responsible for cirDNA rate increasing (active auto-immune disease, 10 days following blood transfusion)
• Patient unable to attend all scheduled visits
• Woman of childbearing age without efficient contraception, breastfeeding
• Patient with a legal protection measure (guardianship, curatorship)
• Vulnerable patient protected by law

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

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: December 17, 2021
• First Posted: December 21, 2021
• Study Start: February 15, 2022
• Primary Completion: July 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (1)