Molecular and immune profiling of lung signet ring cell carcinoma in Chinese patients
Official title: Multi Omics Molecular Characteristics and Immunophenotyping of Lung Signet Ring Cell Carcinoma
Run by First People's Hospital of Hangzhou · NCT07207278 · Data updated 2026-11-12
This project will see if genetic and immune profiling of untreated Chinese patients with lung signet ring cell carcinoma can find molecular markers and immune subtypes, and patients with ALK fusions and specific immune patterns may receive targeted TKI treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT07207278 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with histologically confirmed, previously untreated primary lung signet ring cell carcinoma who can provide adequate FFPE tumor and paired adjacent tissue, have expected survival of at least 12 weeks, and can give informed consent are ideal candidates.
✕Probably not a fit
Patients who have received prior systemic anticancer therapy, have metastatic signet ring cell carcinoma originating from a non-lung primary, concurrent other malignancies, inadequate tissue or incomplete data, or who are pregnant or breastfeeding are unlikely to benefit from the study interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will collect formalin-fixed paraffin-embedded tumor and paired adjacent tissues from 39 previously untreated Chinese patients with lung signet ring cell carcinoma to establish a molecular database. Whole-exome sequencing will identify single nucleotide variants, copy number alterations, and gene fusions, while RNA sequencing will identify differentially expressed genes and define immune subtypes. Multiplex immunohistochemistry will quantify immune cell populations and spatial features of the tumor immune microenvironment. Clinical follow-up and treatment of ALK-positive or specific TIME-subtype patients with tyrosine kinase inhibitors will be used to correlate molecular and immune signatures with treatment outcomes.
Why it matters
Potential benefit: If successful, the project could reveal biomarkers and immune signatures that help personalize diagnosis and guide targeted therapy for Chinese patients with this rare lung cancer.
How similar studies have gone: Multi-omics profiling and immunophenotyping have informed biomarkers and treatment decisions in other lung cancer subtypes and ALK-rearranged tumors often respond well to TKIs, but comprehensive multi-omics characterization specifically for lung signet ring cell carcinoma is largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.Histologically confirmed, previously untreated LSRCC; 2. Adequate FFPE tumor tissue and paired adjacent non-tumor tissue available; 3. Expected survival ≥ 12 weeks; 4. Patients (or their legal guardians) willing and able to provide written informed consent; 5.Availability of complete pathology and imaging data. Exclusion Criteria: 1\. Prior systemic anticancer therapy; 2. Secondary LSRCC (i.e., metastatic signet ring cell carcinoma originating from a non-lung primary site); 3. Concurrent other malignancies; 4. Incomplete pathology results, missing imaging data, or unreliable follow-up information; 5. Pregnancy or lactation
Where it's running
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Centre of Translational Medicine, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Shirong Zhang
- Email: shirleyz4444@zju.edu.cn
- Phone: +86-0571-56007664
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.