The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).
Geriatric assessment allows oncologists to stratify older cancer patients into risk categories (fit, vulnerable and frail) but few patients benefit from it. Yet, they do not evaluate physiological reserves when oncologists are in dire need of quantitative tools accounting for age-related changes. This decade has witnessed the remarkable power of multiple tools (epigenetics, telomere integrity, cellular and immunosenescence) to estimate an individual's age. These tools hold the potential for routine implementation in the clinic and to be combined with existing tests. The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve to improve prognosis assessment in older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC). The ambition of this study is to refine the prognosis assessment and optimize decision-making process, better anticipate adverse-events and unplanned hospitalization and better manage and care high risk patients of early death, unplanned hospitalization, major complication or toxicities and altered quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
385
Blood samples (5 ml) during surgery or within 3 days before.
Henri Mondor Hospital
Créteil, Île-de-France Region, France
RECRUITINGUnplanned hospitalizations within 12 months
Number of unplanned hospitalizations within 12 months
Time frame: 12 months post surgery
Mortality (all-cause) and cause-specific
Number of death (all-cause) and cause-specific at Month12 and Month 60
Time frame: Month 12 and Month 60 post surgery
Surgical Complications
Scores on the Clavien-Dindo Scale at Month 3 and Month 6
Time frame: Month 3 and Month 6 post surgery
Major Toxicities
Scores on the NCI-PRO-CTCA (National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale (Lickert scale with 5 levels/item) at Month 3 . A higher score means worse outcome.
Time frame: Month 3 and Month 6 post surgery
Quality of Life Core 30
Scores on the Quality of Life (QLQ) patients self-questionnaires Core 30 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
Time frame: Month 6 and Month 12 post surgery.
Quality of Life Lung Cancer 13
Scores on the Quality of Life (QLQ) patients self-questionnaires Lung Cancer 13 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
Time frame: Month 6 and Month 12 post surgery
Quality of Life Elderly 14
Scores on the Quality of Life (QLQ) patients self-questionnaires Elderly 14 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
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Time frame: Month 6 and Month 12 post surgery
Disease-free survival
Disease-free survival on imaging (CT scan) at Month 3, Month 6, Month 12 and Month 60
Time frame: Month 3, Month 12 and Month 60 post surgery
Geriatric Parameters G-CODE
Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome.
Time frame: Month 3 and Month 6 post surgery
Geriatric Parameters Hand grip
Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome.
Time frame: Month 3 and Month 6 post surgery