Clinical trial NCT04939324: Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer
Official title: Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Exosomes
Non Small Cell Lung Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Surgical resection remains the best chance for cure in patients with early-stage non-small-cell lung cancer (NSCLC). Unfortunately, approximately 30-50% of patients will relapse within 5-year of curative surgery despite early TNM-stage. The Identification of prognostic biomarkers of relapse is a necessity. Among them, extracellular vesicles (exosomes) study seems promising in early stage cancers and samples directly in tumor-draining vein to. The pulmonary vein is draining blood directly from the lungs and sampling at this location could provide a higher yield for oncosome. The litterature reports that Navarro et al. are the only team to have link exosome characteristics to oncological outcomes following surgery. The investigators propose to analyze the molecular profiling mediated by these extracellular vesicles in the tumor-draining vein of operated patients.

A peripheral blood sample is recolted before surgery (D-1 or D0). During oncological lung surgery, the pulmonary tumor-drainage vein is first exposed and punctured with a needle prior to subsequent surgical manipulation for resection (D0). A piece of resected tumor will be analyzed for the study (D0). Quantification and size distribution of exosome and molecular cargo of exosome in blood samples (peripheral and pulmonary vein) and tumor are analyzed (DNA sequencing).

Standard clinical and radiological follow-up is then performed and 2-year overall survival and 2-year disease free-survival are checked.

Eligibility criteria: Inclusion Criteria:

- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan

Exclusion Criteria:

* Pure ground glass nodule,
* Neoadjuvant therapy,
* Second cancer or cancer in the 5 years,
* Pregnancy,
* Patients \<18 years-old,
* Tutorship

Primary outcomes:
measure: Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
timeFrame: 36 months
Secondary outcomes:
measure: Size distribution, molecular profiling of peripheral vein exosome sat inclusion
timeFrame: 36 months
measure: Mutations and polymorphism in resected lung cancer
timeFrame: 36 months
measure: Overall survival
timeFrame: 36 months
measure: Two-year disease-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Jérémy Tricard, MD
role: PRINCIPAL_INVESTIGATOR
References: