Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 385
- Locations
- 2
- Primary Endpoint
- Unplanned hospitalizations within 12 months
Study Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 70 years and over
- •Local or locally advanced (Clinic stage I-IIIA) NSCLC (clinically (or radiologically) suspected or histologically proven)
- •Surgical Curative Intent
- •Signed informed Consent (or signed by the curator or tutorship)
- •Affiliated to social security administrative care service
Exclusion Criteria
- •Synchronous cancer (histologically proven or strongly suspected non-lung cancer in the 6 months prior to inclusion (excluding basal cell cancer and prostate cancer with local treatment (radiotherapy or surgery) or active surveillance without systemic treatment (chemotherapy, hormone therapy)).
- •Subject deprived of liberty by judicial or administrative decision or patient under guardianship
- •Subject unable to understand the purpose and conditions of the study and unable to give consent
Outcomes
Primary Outcomes
Unplanned hospitalizations within 12 months
Time Frame: 12 months post surgery
Number of unplanned hospitalizations within 12 months
Secondary Outcomes
- Mortality (all-cause) and cause-specific(Month 12 and Month 60 post surgery)
- Surgical Complications(Month 3 and Month 6 post surgery)
- Major Toxicities(Month 3 and Month 6 post surgery)
- Quality of Life Core 30(Month 6 and Month 12 post surgery.)
- Quality of Life Lung Cancer 13(Month 6 and Month 12 post surgery)
- Quality of Life Elderly 14(Month 6 and Month 12 post surgery)
- Disease-free survival(Month 3, Month 12 and Month 60 post surgery)
- Geriatric Parameters G-CODE(Month 3 and Month 6 post surgery)
- Geriatric Parameters Hand grip(Month 3 and Month 6 post surgery)
- Mortality (all-cause) and cause-specific(Month 12 and Month 60 post surgery)
- Surgical Complications(Month 3 and Month 6 post surgery)
- Major Toxicities(Month 3 and Month 6 post surgery)
- Quality of Life Core 30(Month 6 and Month 12 post surgery.)
- Quality of Life Lung Cancer 13(Month 6 and Month 12 post surgery)
- Quality of Life Elderly 14(Month 6 and Month 12 post surgery)
- Disease-free survival(Month 3, Month 12 and Month 60 post surgery)
- Geriatric Parameters G-CODE(Month 3 and Month 6 post surgery)
- Geriatric Parameters Hand grip(Month 3 and Month 6 post surgery)