NCT06629714

Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and Lung Cancer Patients

Cohort Studies of Impact of Pretreatment Emotional on Survival and the Predictive Role of Peripheral Blood Metabolic and Inflammatory Markers in Immunotherapy Response Among Treatment-Naïve, Advanced and Inoperable Gastroesophageal and Non-Small-Cell Lung Cancer Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).

Detailed description

This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts: * Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients. * Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.

Conditions

• Non Small Cell Lung Cancer
• Immune Checkpoint Inhibitors
• Inflammation
• Cancer, Treatment-Related
• Emotional Distress
• Gastroesophageal Cancer (GC)
• Biomarkers / Blood
• Progression-free Survival, PFS

Interventions

Type	Name	Description
OTHER	Exposure: emotional distress status	The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a sum score of PHQ-9 and GAD-7 ≥ 10 were categorized as the stressed group.

Timeline

• Start date: 2020-10-16
• Primary completion: 2025-04-20
• Completion: 2025-04-20
• First posted: 2024-10-08
• Last updated: 2026-01-13

Locations

1 site across 1 country: China