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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05267041

Collaborator

(none)

4,000

Enrollment

Location

Arm

240

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Quality of life questionnaire Biological: Blood sample Other: Quality of life questionnaire Other: Quality of life questionnaire Other: Quality of life questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 treatmentOne 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)

Primary Purpose:

Other

Official Title:

Prospective Longitudinal Cohort Associated to Blood Collection, Pathological Samples Collection, and Radiological and Pathological Imaging Collection

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2032

Anticipated Study Completion Date :

May 1, 2042

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort of Adults with lung cancer Patients newly diagnosed with lung cancer.	Other: Quality of life questionnaire One questionnaire between diagnostic annoucement and first line treatement Biological: Blood sample One optional veinous blood sampling (24 ML) between the first diagnostic annoucement and before the first treatment for lung cancer Other: Quality of life questionnaire One questionnaire 6 months later after first line treatment Other: Quality of life questionnaire One questionnaire before second line treatment Other: Quality of life questionnaire One questionnaire 6 months later after second line treatment

Arm

Intervention/Treatment

Experimental: Cohort of Adults with lung cancer

Patients newly diagnosed with lung cancer.

Other: Quality of life questionnaire

One questionnaire between diagnostic annoucement and first line treatement

Biological: Blood sample

One optional veinous blood sampling (24 ML) between the first diagnostic annoucement and before the first treatment for lung cancer

Other: Quality of life questionnaire

One questionnaire 6 months later after first line treatment

Other: Quality of life questionnaire

One questionnaire before second line treatment

Other: Quality of life questionnaire

One questionnaire 6 months later after second line treatment

Outcome Measures

Primary Outcome Measures

Number of participants registered in the lung cancer database [20 years]
cohort open to recruitment during 10 years with 10 years of patients follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Lyon Sud	Pierre-Bénite		France	69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05267041

Other Study ID Numbers:

69HCL21_1175

First Posted:

Mar 4, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Data collection

lung cancer

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Apr 25, 2022