NCT05648188

Brief Summary

Early non-small cell lung cancer (NSCLC), treated by surgery or radiotherapy in the case of inoperability, relapses in almost 50% of cases. Circulating tumour cells (CTCs), which can be detected before surgery, represent a promising prognostic tool, but the markers characterising their aggressiveness remain to be determined. The NSCLC microenvironment, in which purinergic signalling is a key pathway, controls tumour development. Adenosine derived from the action of CD39 and CD73 ectonucleotidases hydrolysing extracellular ATP, induces immunosuppression of NSCLC by activating A2R receptors. The expression and prognostic relevance of A2R, CD39 and CD73 on CTCs is unknown. The objectives are to (i) compare the expression of A2R and CD39 and CD73 on primary tumour cells and CTCs of patients operated on for early NSCLC, (ii) correlate these data with molecular characteristics and clinical response, (iii) determine on lung cancer lines whether irradiation impacts on the expression of A2R, CD39 and CD73. This work could contribute to the identification of new theranostic biomarkers.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

December 5, 2022

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ex vivo expression of A2R (adenosine receptor), CD39, CD73 and P2RX7 on NSCLC and CTC

    Presence versus Absence of expression (immunohistochemistry)

    At inclusion

Secondary Outcomes (1)

  • In vitro impact of radiation therapy on the A2R, CD39, CD73 expression by cells lineage

    At inclusion

Study Arms (1)

NSCLC patients

Patients with proven stage IA-IIB non-small cell lung cancer (NSCLC).

Biological: Sample

Interventions

SampleBIOLOGICAL

Sample of whole blood and tissue for ex vivo expression of A2R, CD39, CD73 and P2RX7

NSCLC patients

Eligibility Criteria

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

Patients operated for a localized NSCLC (IA-IIB stage) in Nice University Hospital, Thoracic Surgery service.

You may qualify if:

  • Patient of legal age (\>18 years), any gender,
  • operated on for stage (IA to IIB) non-small cell lung cancer (NSCLC)

You may not qualify if:

  • Patient with any other active cancer.
  • Lack of evaluable material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06001, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (20 ml). tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jonathan BENZAQUEN, Dr

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

January 1, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations