- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07779005
The Shengjing Lung Cancer Cohort (SJ-LCC) Study on Risk Factors for Disease Development and Progression (SJ-LCC)
The Shengjing Lung Cancer Cohort (SJ-LCC) Study
Modifiable risk factors, including smoking, alcohol consumption, and diet, play critical roles in cancer progression and patient prognosis. In patients diagnosed with lung cancer, these risk factors not only directly modulate host metabolism and immune regulation, but also exert indirect effects by altering the internal milieu, such as the gut microbiota-potentially exerting a profound impact on long-term clinical trajectories.
Leveraging a well-characterized, longitudinally followed cohort of confirmed lung cancer patients, this study systematically assesses habitual dietary intake, emotional well-being, lifestyle behaviors, and related variables using validated instruments, including the Food Frequency Questionnaire (FFQ). Furthermore, the study integrates multidimensional biomarker profiling across tumor tissue, blood, urine, and fecal samples. By linking exposure profiles, multi-omics data, and long-term clinical follow-up records, this project aims to:
- Evaluate Prognostic Associations: Investigate the relationships between exposure profiles (e.g., dietary patterns) and long-term clinical outcomes in lung cancer patients, including progression-free survival (PFS), overall survival (OS), and recurrence risk.
- Elucidate Biological Mechanisms: Unravel the underlying mechanisms by which the "exposure profile-multi-omics" axis mediates lung cancer progression, and identify candidate biomarkers with predictive value for clinical prognosis.
Ultimately, this study aims to establish evidence-based healthy lifestyle recommendations for patients and provide healthcare professionals with translational insights to inform precision nutrition and targeted intervention strategies across the continuum of lung cancer care.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Huanhuan Chen Dr.Chen
- Numéro de téléphone: +86 18940255489
- E-mail: 20152214@cmu.edu.cn
Lieux d'étude
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Liaoning
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Shenyang, Liaoning, Chine, 110000
- Recrutement
- Shengjing Hospital affiliated to China Medical University
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Contact:
- Huanhuan Chen Dr.Chen
- Numéro de téléphone: +86 18940255489
- E-mail: 20152214@cmu.edu.cn
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients aged between 18 and 75 years;
- Patients with newly, pathologically confirmed lung cancer;
- Patients diagnosed within the preceding 6 months (time since confirmed diagnosis < 6 months).
Exclusion Criteria:
- Individuals aged outside the range of 18-75 years, or those in poor general physical condition who are unable to cooperate with the questionnaire survey;
- Patients with non-primary lung cancer, non-newly diagnosed lung cancer, or those unable to provide definitive pathological confirmation;
- Individuals with severe depression, pregnant women, or those diagnosed with severe cardiovascular/cerebrovascular diseases or severe metabolic dysfunctions affecting the liver, kidneys, or other major organs;
- Individuals unwilling to participate in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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6-Month Progression-Free Survival (PFS) Rate
Délai: 6 months
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6 months
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Overall Survival (OS)
Délai: From enrollment through study completion, up to 10 years
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From enrollment through study completion, up to 10 years
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2020PS556K
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