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

Primary Purpose

Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quality of life questionnaire
Blood sample
Quality of life questionnaire
Quality of life questionnaire
Quality of life questionnaire
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Data collection, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort of Adults with lung cancer

Arm Description

Patients newly diagnosed with lung cancer.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2022
Last Updated
April 22, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05267041
Brief Title
Joint Thoracic Oncology Research Unit of LYon: Lung cancerS DatabaSE (ULYSSE)
Acronym
ULYSSE
Official Title
Prospective Longitudinal Cohort Associated to Blood Collection, Pathological Samples Collection, and Radiological and Pathological Imaging Collection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2032 (Anticipated)
Study Completion Date
May 2042 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Data collection, lung cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort of Adults with lung cancer
Arm Type
Experimental
Arm Description
Patients newly diagnosed with lung cancer.
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
One questionnaire between diagnostic annoucement and first line treatement
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
One optional veinous blood sampling (24 ML) between the first diagnostic annoucement and before the first treatment for lung cancer
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
One questionnaire 6 months later after first line treatment
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
One questionnaire before second line treatment
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
One questionnaire 6 months later after second line treatment
Primary Outcome Measure Information:
Title
Number of participants registered in the lung cancer database
Description
cohort open to recruitment during 10 years with 10 years of patients follow-up
Time Frame
20 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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