Joint Thoracic Oncology Research Unit of LYon: Lung cance... | NCT05267041

Studies
Joint Thoracic Oncology Research Unit of LYon: Lung cancerS DatabaSE (ULYSSE)

NCT05267041

Sponsor

Hospices Civils de Lyon

Status

Recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

4,000Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Blood sample
Questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2022Actual

Primary Completion Date

May 5, 2032Estimated

Completion Date

May 5, 2042Estimated

First Submitted Date

Feb 14, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective longitudinal cohort associated to blood collection, pathological samples collection, and radiological and pathological imaging collection.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort of Adults with lung cancer	Experimental	Patients newly diagnosed with lung cancer.	Biological: Blood sample Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Biological	One optional veinous blood sampling (24 ML) between the first diagnostic annoucement and before the first treatment for lung cancer	Cohort of Adults with lung cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants registered in the lung cancer database	cohort open to recruitment during 10 years with 10 years of patients follow-up	20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient treated for a thoracic cancer in the Lyon University Hospital: non-small cell lung cancer, small cell lung cancer, mesothelioma…
Diagnosis can be done:
- By cytology or pathologic assessment
- Or by multidisciplinary team meeting decision:
  - Irradiation without morpho-metabolic sampling
  - Treatment without sampling based on non-invasive molecular data

Exclusion Criteria:

- Refusal to participate

For optional blood sampling :

< 30 kg for blood collection
No blood sampling schedule for care

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Lyon Sud	Recruiting	Pierre-Bénite		69495	France

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

One questionnaire between diagnostic annoucement and first line treatement One 6 months later One before second line treatment One 6 months later after second line treatment Optionnal Veinous Blood Sample (28 mL) between the diagnostic annoucement and the first line of treatment