Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer
ExOnSite-Pro
Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce
1 other identifier
interventional
30
1 country
1
Brief Summary
This is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. The main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Jun 2021
Typical duration for not_applicable lung-cancer
1 active site
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
May 31, 2021
CompletedStudy Start
First participant enrolled
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2024
CompletedApril 10, 2023
April 1, 2023
2.2 years
May 31, 2021
April 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
Concentration of extracellular vesicule (million of particule/mL of blood)
36 months
Secondary Outcomes (4)
Size distribution, molecular profiling of peripheral vein exosome sat inclusion
36 months
Mutations and polymorphism in resected lung cancer
36 months
Overall survival
36 months
Two-year disease-free survival
24 months
Study Arms (1)
Blood samples at 2 sites: peripheral vein and tumor-draining vein
OTHERD0: surgery (inclusion): oncological lung resection * Blood samples at 2 sites: peripheral vein and tumor-draining vein * Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call)
Interventions
D0: surgery (inclusion): oncological lung resection * Blood samples at 2 sites: peripheral vein and tumor-draining vein * Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call)
Eligibility Criteria
You may qualify if:
- \- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan
You may not qualify if:
- Pure ground glass nodule,
- Neoadjuvant therapy,
- Second cancer or cancer in the 5 years,
- Pregnancy,
- Patients \<18 years-old,
- Tutorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Limoges
Limoges, 87042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérémy Tricard, MD
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2021
First Posted
June 25, 2021
Study Start
June 21, 2021
Primary Completion
August 21, 2023
Study Completion
June 6, 2024
Last Updated
April 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share