Lung CancerExOnSite-ProNCT04939324
Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer
A study testing Blood samples at 2 sites: peripheral vein and tumor-draining vein in people with Lung Cancer and Exosomes, run by University Hospital, Limoges at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Exosomes, Non Small Cell Lung Cancer
- What is being tested?
- Blood samples at 2 sites: peripheral vein and tumor-draining vein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2021to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan
Who cannot join
- Pure ground glass nodule,
- Neoadjuvant therapy,
- Second cancer or cancer in the 5 years,
- Pregnancy,
- Patients <18 years-old,
- Tutorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce
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.
Read the 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.
- Conditions
- Lung Cancer, Exosomes, Non Small Cell Lung Cancer
- Being tested
- Blood samples at 2 sites: peripheral vein and tumor-draining vein
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples at 2 sites: peripheral vein and tumor-draining veinBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Blood samples at 2 sites: peripheral vein and tumor-draining vein | Other | 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) Receives: Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
Concentration of extracellular vesicule (million of particule/mL of blood)
Measured: 36 months
Secondary outcomes (4)
Size distribution, molecular profiling of peripheral vein exosome sat inclusion
The size distribution of extracellular vesicules harvested
Measured: 36 months
Mutations and polymorphism in resected lung cancer
Analyze of the molecular profile in the resected tumor tissus
Measured: 36 months
Overall survival
overall survival
Measured: 36 months
Two-year disease-free survival
Two-year disease-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start21 Jun 2021
- Primary completion25 Jun 2024
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy Tricard, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939324
- Sponsor's protocol ID
- 87RI20-0067 (ExOnSite-Pro)
- Acronym
- ExOnSite-Pro
- Status last verified
- Jun 2026
- First submitted
- 31 May 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tricard J, Durand S, Rovini A, Gateau A, Negroni L, Chaunavel A, Chermat A, Jauberteau MO, Conti M, Akil H, Lalloue F. New proteomic signature in circulating extracellular vesicles from tumor-draining and peripheral veins of patients with lung adenocarcinoma. Cancer Cell Int. 2026 Apr 1;26(1):192. doi: 10.1186/s12935-026-04264-9.
PubMed 41923119
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce
- ClinicalTrials.gov ID
- NCT04939324
- Acronym / sponsor ID
- ExOnSite-Pro / 87RI20-0067 (ExOnSite-Pro)
- Conditions
- Lung Cancer, Exosomes, Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood samples at 2 sites: peripheral vein and tumor-draining vein | Other | Biological: Blood samples at 2 sites: peripheral vein and tumor-draining veinD0: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan
Key exclusion criteria (6 listed)
- Pure ground glass nodule,
- Neoadjuvant therapy,
- Second cancer or cancer in the 5 years,
- Pregnancy,
- Patients <18 years-old,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples at 2 sites: peripheral vein and tumor-draining veinD0: 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) | Biological | Blood samples at 2 sites: peripheral vein and tumor-draining vein |
Primary outcome
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
Time frame: 36 months
Concentration of extracellular vesicule (million of particule/mL of blood)
4 secondary outcomes
Size distribution, molecular profiling of peripheral vein exosome sat inclusion
Time frame: 36 months
Mutations and polymorphism in resected lung cancer
Time frame: 36 months
Overall survival
Time frame: 36 months
Two-year disease-free survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 41923119Tricard J, Durand S, Rovini A, Gateau A, Negroni L, Chaunavel A, Chermat A, Jauberteau MO, Conti M, Akil H, Lalloue F. New proteomic signature in circulating extracellular vesicles from tumor-draining and peripheral veins of patients with lung adenocarcinoma. Cancer Cell Int. 2026 Apr 1;26(1):192. doi: 10.1186/s12935-026-04264-9.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérémy Tricard, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples at 2 sites: peripheral vein and tumor-draining vein in people with Lung Cancer and Exosomes, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.