RecruitingNCT07207278

Multi Omics Molecular Characteristics and Immunophenotyping of Lung Signet Ring Cell Carcinoma

Sponsor

First People's Hospital of Hangzhou

Enrollment

39 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Signet Ring Cell Carcinoma of the Lung

Summary

This study aims to reveal the molecular characteristics and immune microenvironmental profile of signet ring cell carcinoma of the lung (LSRCC) in the Chinese population through integrated multi-omics analyses. The project plans to enroll formalin-fixed paraffin-embedded (FFPE) tissue samples and paired adjacent tissues from 39 patients with previously untreated LSRCC to establish a Chinese LSRCC molecular database. Whole-exome sequencing (WES) will be used to analyze gene mutations, such as single nucleotide variants (SNVs), copy number variants (CNVs), and fusion events. RNA-seq will be used to screen for differentially expressed genes (DEGs) and perform immunophenotyping, while multiplex immunohistochemistry will be employed to quantify the tumor immune microenvironment (TIME). The successful implementation of this project is expected to identify novel molecular biomarkers specific to the Chinese LSRCC population, enhance understanding of the unique immune phenotypes within this group, and-combined with clinical follow-up-establish correlations between molecular/immune signatures and therapeutic efficacy assessments, thereby providing evidence-based medical support for subsequent personalized precision diagnosis and treatment of LSRCC in this population.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting and analyzing tumor samples from patients with a rare type of lung cancer called lung signet ring cell carcinoma (LSRCC). By examining the genetic makeup and immune characteristics of these tumors, researchers hope to better understand this cancer and identify potential targets for new treatments. **You may be eligible if...** - You have been diagnosed with LSRCC confirmed by pathology (tissue examination) - You have not previously received any systemic cancer treatment - You have adequate tumor tissue (preserved tumor sample) and matching non-tumor tissue available - Your expected survival is at least 12 weeks - Complete pathology and imaging data are available - You (or your legal guardian) are willing to provide written informed consent **You may NOT be eligible if...** - You have previously received systemic anti-cancer therapy - Your cancer originated outside the lung and spread to the lung (secondary LSRCC) - You have another active cancer at the same time - Your pathology results are incomplete, imaging data is missing, or follow-up information is unreliable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPatients with specific TIME subtype and ALK fusion mutations (confirmed via RNA-seq and OncoKB annotation) will receive tyrosine kinase inhibitors (TKIs, e.g., alectinib or crizotinib) as first-line

Patients with specific TIME subtype and ALK fusion mutations (confirmed via RNA-seq and OncoKB annotation) will receive tyrosine kinase inhibitors (TKIs, e.g., alectinib or crizotinib) as first-line therapy. Clinical response will be assessed via RECIST v1.1 criteria using serial CT imaging (baseline, 8 weeks, and every 12 weeks thereafter). Correlative analyses will evaluate TKI efficacy in relation to TIME subtype, ALK fusion variant, and multi-omic signatures.

Locations(1)

Centre of Translational Medicine, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine

Hangzhou, Zhejiang, China

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NCT07207278