Changhai Multimodal Esophageal Cancer Cohort

Active, not recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Diagnostic Test: DNA Sequencing, RNA Sequencing

• Registration Number: NCT06410677
• Lead Sponsor: Wangluowei

Brief Summary

The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-13
• Primary Completion: 2022-10-21
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Availability of Hematoxylin and Eosin (H&E) stained images, molecular data obtained through RNA sequencing (RNA-Seq, DNA-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, AJCC Tumor, Node, Metastasis Stage, specific location of oesophageal cancer occurrence, and history of reflux.
2. The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.

Exclusion Criteria

1. Patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers;
2. Cases involving combined adenocarcinoma affecting the gastroesophageal junction;
3. Individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination;
4. Subjects in whom postoperative pathology confirms an absence of residual malignant tissue.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
esophageal squamous cell carcinoma	DNA Sequencing, RNA Sequencing	-

Primary Outcome Measures

Name	Time	Method
Immunogene signatures with predictive value for immunotherapy of ESCC	After undergoes surgery.

Secondary Outcome Measures

Name	Time	Method
Prognosis and immunotherapy tolerance in ESCC patients	Follow-up for at least 1 year after undergoing surgery	The prognosis was determined through follow-up, while tolerance to immunotherapy was anticipated utilizing gene sequencing methodologies.

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, China