Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

NCT ID: NCT05306912

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2026-12-31

Brief Summary

Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool.

Complementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (<3% complications) but of limited sensitivity in cases of nodules < 20 mm.

The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity

Detailed Description

Tumor biopsy is often required to characterize indeterminate nodules. Radial endobronchial ultrasound (rEBUS) bronchoscopy is often used due to a low rate of complications but its sensitivity is limited for small nodules.

The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity.

The primary outcome of this pilot, diagnostic validation, monocentric study is the sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule.

Secondary outcomes include the comparison of supernatant to pathology and plasma cfDNA methylation analysis.

Specificity, negative predictive value (NPV), positive predictive value (PPV) of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be analyzed.

60 patients planned for a rEBUS bronchoscopy for one, two or three < 20 mm nodule, without mediastinal or extra thoracic lesions (cT1N0M0) will be included.

The day of the rEBUS bronchoscopy, 2 7.5 mL blood samples are collected. rEBUS samples' supernatant, usually discarded, is saved.

Cell free DNA is extracted from these biological specimens at the Laboratory of Oncological Medical Biology (LBMO) in Toulouse University Cancer Institute and tested for methylation (targeted analysis on 9 genes).

The patients will be followed for one year to obtain a final diagnosis and correlate it with tissue, nodule supernatant and plasma methylation analyses.

Conditions

Lung Cancer; Lung; Node

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

blood sampling

blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: BIOLOGICAL

Patients will be taken from an additional blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma.

Interventions

Blood samples

Patients will be taken from an additional blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• rEBUS bronchoscopy planned for one, two or three ≤ 20 mm nodule
• World Health Organization (WHO) Performance status 0-3
• Informed signed consent
• Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage).

Exclusion Criteria

• Lung cancer diagnosed before the date of the procedure
• Lung cancer strongly suspected due to mediastinal or extra thoracic lesions
• Patient under State Medical Assistance
• Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentin HELUAIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Toulouse University Hospital

Toulouse, Occitanie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Valentin HELUAIN, MD

Role: CONTACT

heluain.v@chu-toulouse.fr

+33567771439 ext. +33

Facility Contacts

Sandra BERNARD, PM

Role: primary

bernard.s@chu-toulouse.fr

+33561778573

Other Identifiers

ID-RCB 2021-A01024-37

Identifier Type: OTHER

Identifier Source: secondary_id

ARI 20-0446

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/20/0446

Identifier Type: -

Identifier Source: org_study_id