Cancer of the Lung And SeneScencE - Prospective Cohort 1

Not Applicable

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT06923618
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2025-02-17
• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2028-04
• Study Completion: 2032-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Unplanned hospitalizations within 12 months	12 months post surgery	Number of unplanned hospitalizations within 12 months

Secondary Outcome Measures

Name	Time	Method
Mortality (all-cause) and cause-specific	Month 12 and Month 60 post surgery	Number of death (all-cause) and cause-specific at Month12 and Month 60
Major Toxicities	Month 3 and Month 6 post surgery	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 and Month 6. A higher score means worse outcome.
Quality of Life Core 30	Month 6 and Month 12 post surgery.	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.
Surgical Complications	Month 3 and Month 6 post surgery	Scores on the Clavien-Dindo Scale at Month 3 and Month 6
Disease-free survival	Month 3, Month 12 and Month 60 post surgery	Disease-free survival on imaging (CT scan) at Month 3, Month 12 and Month 60
Geriatric Parameters G-CODE	Month 3 and Month 6 post surgery	Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome.
Quality of Life Lung Cancer 13	Month 6 and Month 12 post surgery	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.
Quality of Life Elderly 14	Month 6 and Month 12 post surgery	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.
Geriatric Parameters Hand grip	Month 3 and Month 6 post surgery	Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome.

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Créteil, Île-de-France, France