NCT04624373

Brief Summary

The wide uptake of "liquid biopsy" diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions…) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

November 9, 2020

Last Update Submit

March 31, 2025

Conditions

Lung Cancer

Keywords

NSCLCgenotypingliquid biopsycytology supernatant

Outcome Measures

Primary Outcomes (1)

  • main aim of the study

    to investigate the sensitivity of sfDNA genotyping in various clinical settings and to compare it to cell block

    18 months

Secondary Outcomes (6)

  • TMB estimation

    18 months

  • sensitivity of plasma

    18 months

  • concordance between plasma and supernatant

    18 months

  • mutation rate

    18 months

  • Sensitivity of supernatant and plasma

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Identified mutation

The sensitivity of supernatant to identify the mutations detected on cell block (Gold standard).

Other: Molecular analysis of surnatant

Non identified mutation

The sensitivity of supernatant to identify the mutations detected on cell block (Gold standard).

Other: Molecular analysis of surnatant

Interventions

Molecular analysis of surnatantOTHER

The interventional pulmonologist selects the most suspect node. The corresponding TBNA is placed in Cytolyt and tagged using a sticker to indicate the specimen from which supernatant must be saved after the initial spin. The supernatant is transferred to the "Laboratoire de Biologie Médicale Oncologique" where it undergoes a further hard spin. The remaining supernatant is stored at -80°C before to send it to Foundation One for DNA extraction from 3 ml of supernatant and genotyping. Two 7,5 mL blood tubes are transferred to the laboratory to extract plasma. Plasma was stored at -80°C and then sent to Foundation One for DNA extraction from 2 mL of plasma and genotyping. 10 slides from the cell block are shipped to Foundation One. These specimens are tested by FoundationOne®CDX (tissue), and FoundationOne®Liquid (supernatant and plasma) for genomic and TMB analyses (hybrid-capture based next generation sequencing).

Identified mutationNon identified mutation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited in our Department in Toulouse University Hospital, during appointment needed for information and planning of the EBUS-TBNA procedure.

You may qualify if:

  • Age \> 18 years-old
  • Patients planned for an EBUS-TBNA for
  • Suspicion of stage IV lung cancer (PET+ mediastinal node(s)) (Cohort 1)
  • Stage IV NSCLC with an EGFR, BRAF, HER2, MET mutation or ALK, RET or ROS1 rearranged NSCLC and acquired resistance to targeted therapy (Cohort 2)
  • Performance status 0-3
  • Informed consent

You may not qualify if:

  • Refusal to participate
  • Patient under legal tutelage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nicolas Guibert

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nicolas Guibert

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Guibert, MD

CONTACT

567778160guibert.n@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 10, 2020

Study Start

April 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations

FR(1)