Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646471
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMETHEE
Brief Summary:
The objective of the study is to prospectively generate real-life data in patients aged 70 years treated in first line for a thoracic tumor Non-Small-Cell Lung Carcinoma according to best standard of care as defined by the European Society for Medical Oncology ESMO This cohort will aim to
characterize participants in terms of geriatrics biology and carcinology
describe the treatment modalities by stage as well as the results in terms of efficacy safety and impact on quality of life
At the same time exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule andor the same innovative strategy
Participants will be followed in accordance with investigators usual clinical practice at the corresponding site They will be asked to
visit the clinic as per physicians request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment
perform the necessary regular para-clinical examinations lab testing imaging re-biopsy
provide blood samples for bio-bank repository
perform assessments specific to older adults
answer three quality of life questionnaires
characterize participants in terms of geriatrics biology and carcinology
describe the treatment modalities by stage as well as the results in terms of efficacy safety and impact on quality of life
At the same time exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule andor the same innovative strategy
Participants will be followed in accordance with investigators usual clinical practice at the corresponding site They will be asked to
visit the clinic as per physicians request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment
perform the necessary regular para-clinical examinations lab testing imaging re-biopsy
provide blood samples for bio-bank repository
perform assessments specific to older adults
answer three quality of life questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None