Clinical trial NCT06923618: Cancer of the Lung And SeneScencE - Prospective Cohort 1
Official title: Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Aging biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 385
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients 70 years and over
* Local or locally advanced (Stage I-IIIA) NSCLC
* Surgical Curative Intent
* Signed informed Consent (or signed by the curator or tutorship)
* Affiliated to social security administrative care service

Exclusion Criteria:

* Synchronous cancer
* 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

Primary outcomes:
measure: Unplanned hospitalizations within 12 months
timeFrame: 12 months post surgery
Secondary outcomes:
measure: Mortality (all-cause) and cause-specific
timeFrame: Month 12 and Month 60 post surgery
measure: Surgical Complications
timeFrame: Month 3 and Month 6 post surgery
measure: Major Toxicities
timeFrame: Month 3 and Month 6 post surgery
measure: Quality of Life Core 30
timeFrame: Month 6 and Month 12 post surgery.
measure: Quality of Life Lung Cancer 13
timeFrame: Month 6 and Month 12 post surgery
measure: Quality of Life Elderly 14
timeFrame: Month 6 and Month 12 post surgery
measure: Disease-free survival
timeFrame: Month 3, Month 12 and Month 60 post surgery
measure: Geriatric Parameters G-CODE
timeFrame: Month 3 and Month 6 post surgery
measure: Geriatric Parameters Hand grip
timeFrame: Month 3 and Month 6 post surgery
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
state: Île-de-France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence CANOUÏ-POITRINE, PhD
role: PRINCIPAL_INVESTIGATOR
References: