Cancer of the Lung And SeneScencE - Prospective Cohort 1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
Overview
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.
Interventions
- Biological Blood samples
Blood samples (5 ml) during surgery or within 3 days before.
Primary outcome measures
- Unplanned hospitalizations within 12 months [Time frame: 12 months post surgery]
Secondary outcome measures (9)
- Mortality (all-cause) and cause-specific [Time frame: Month 12 and Month 60 post surgery]
- Surgical Complications [Time frame: Month 3 and Month 6 post surgery]
- Major Toxicities [Time frame: Month 3 and Month 6 post surgery]
- Quality of Life Core 30 [Time frame: Month 6 and Month 12 post surgery.]
- Quality of Life Lung Cancer 13 [Time frame: Month 6 and Month 12 post surgery]
- Quality of Life Elderly 14 [Time frame: Month 6 and Month 12 post surgery]
- Disease-free survival [Time frame: Month 3, Month 12 and Month 60 post surgery]
- Geriatric Parameters G-CODE [Time frame: Month 3 and Month 6 post surgery]
- Geriatric Parameters Hand grip [Time frame: Month 3 and Month 6 post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Henri Mondor Hospital — Créteil
Identifiers
NCT: NCT06923618 · APHP241246 · ID-RCB Number