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L'essai clinique NCT06923618 (CLASSE-P1) pour Cancer du poumon non à petites cellules est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Assistance publique - Hôpitaux de ParisCancer du poumon et sénescence - cohorte prospective 1 (CLASSE-P1)
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L'étude clinique NCT06923618 (CLASSE-P1) est un essai interventionnel pour Cancer du poumon non à petites cellules. Son statut actuel est : en recrutement. L'étude a débuté le 9 juillet 2025 et vise à recruter 385 participants. Dirigé par l'Assistance publique - Hôpitaux de Paris, l'essai devrait être terminé d'ici le 1 juillet 2032. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 20 juillet 2025.
Résumé succinct
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).
Description détaillée
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.
Titre officiel
Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
Conditions
Cancer du poumon non à petites cellulesAutres identifiants de l'essai
- CLASSE-P1
- APHP241246
Numéro NCT
Date de début (réel)
2025-07-09
Dernière mise à jour publiée
2025-07-20
Date de fin (estimée)
2032-07
Inscription (estimée)
385
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Non-Small Cell Lung Cancer
Aging biomarkers
Aging biomarkers
Objectif principal
Diagnostic
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
N/A | ÉCHANTILLONS DE SANG Blood samples (5 ml) during surgery |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Unplanned hospitalizations within 12 months | Number of unplanned hospitalizations within 12 months | 12 months post surgery |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 | 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 and Month 6. 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 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 |
Critères d'éligibilité
Âges éligibles
Adulte âgé
Âge minimum
70 Years
Sexes éligibles
Tous
- 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
- 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
Assistance publique - Hôpitaux de Paris961 essais cliniques actifs à explorerContact central de l'essai
Contact: Florence CANOUÏ-POITRINE, PhD, 01 49 81 36 74, [email protected]
Contact: Alice CAMARA, Project advisor, 01 58 41 12 11, [email protected]
1 Centres de l'essai dans 1 pays
Île-de-France Region
Henri Mondor Hospital, Créteil, Île-de-France Region, 94000, France
Florence CANOUÏ-POITRINE, PhD, Contact, 01 49 81 36 74, [email protected]
En recrutement