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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB Number | Other Identifier | 2024-A02393-44 |
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| Name | Class |
|---|---|
| ARC Foundation and Inserm | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | Blood samples (5 ml) during surgery or within 3 days before. |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned hospitalizations within 12 months | Number of unplanned hospitalizations within 12 months | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality (all-cause) and cause-specific | Number of death (all-cause) and cause-specific at Month12 and Month 60 | Month 12 and Month 60 post surgery |
| Surgical Complications | Scores on the Clavien-Dindo Scale at Month 3 and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence CANOUĂ-POITRINE, PhD | Contact | 01 49 81 36 74 | +33 | florence.canoui-poitrine@aphp.fr |
| Adèle BELLINO, Project advisor | Contact | 01 71 76 07 57 | +33 | adele.bellino@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence CANOUĂ-POITRINE, PhD | Assistance Publique - HĂ´pitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | CrĂŠteil | Ăle-de-France Region | 94000 | France |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Month 3 and Month 6 post surgery |
| Major Toxicities | 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. | Month 3 and Month 6 post surgery |
| Quality of Life Core 30 | 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. | Month 6 and Month 12 post surgery. |
| Quality of Life Lung Cancer 13 | 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. | Month 6 and Month 12 post surgery |
| Quality of Life Elderly 14 | 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. | Month 6 and Month 12 post surgery |
| Disease-free survival | Disease-free survival on imaging (CT scan) at Month 3, Month 6, Month 12 and Month 60 | Month 3, Month 12 and Month 60 post surgery |
| Geriatric Parameters G-CODE | Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome. | Month 3 and Month 6 post surgery |
| Geriatric Parameters Hand grip | Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome. | Month 3 and Month 6 post surgery |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |