Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, Aging biomarkers
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.
Interventions
BIOLOGICALBlood samples
Blood samples (5 ml) during surgery or within 3 days before.
Sponsors
ARC Foundation and Inserm
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospitalizations within 12 months | 12 months post surgery | Number of unplanned hospitalizations within 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | Month 3 and Month 6 post surgery | Scores on the Clavien-Dindo Scale at Month 3 and Month 6 |
| 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 . 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. |
| 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. |
| 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 |
| Disease-free survival | Month 3, Month 12 and Month 60 post surgery | Disease-free survival on imaging (CT scan) at Month 3, Month 6, 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. |
| 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. |
| 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. |
Countries
France
Contacts
Primary ContactFlorence CANOUÏ-POITRINE, PhD
Backup ContactAdèle BELLINO, Project advisor
Outcome results
None listed