Changhai Multimodal Esophageal Cancer Cohort

Esophageal Squamous Cell Carcinoma Clinical Trial

— CMECC  

Official title:

Prediction of Immune Infiltration Level and Immunotherapy Efficacy of Esophageal Squamous Cell Carcinoma Based on Multimodal Deep Learning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06410677
• Other study ID #: CMECC
• Status: Active, not recruiting
• Start date: June 13, 2018
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: October 1, 2024
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Diagnostic Test:
• DNA Sequencing, RNA Sequencing
High-coverage Whole-Exome Sequencing sequencing of DNA samples from ESCC was performed. RNA expression was analyzed using the NanoString PanCancer Immuno-Oncology 360TM Panel that includes a set of more than 700 genes involved in the main biological pathways of human immunity. These experiments were performed by the Genomics platform of Institut Curie. Total RNAs were used as templates.

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Wangluowei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogene signatures with predictive value for immunotherapy of ESCC		After undergoes surgery.
Secondary	Prognosis and immunotherapy tolerance in ESCC patients	The prognosis was determined through follow-up, while tolerance to immunotherapy was anticipated utilizing gene sequencing methodologies.	Follow-up for at least 1 year after undergoing surgery