Changhai Multimodal Esophageal Cancer Cohort

NCT06410677 | Active Not Recruiting

• 1 other identifier: CMECC
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

deep learning; Esophageal Squamous Cell Carcinoma; immune infiltration

Outcome Measures

Primary Outcomes (1)

• Immunogene signatures with predictive value for immunotherapy of ESCC

  After undergoes surgery.

Secondary Outcomes (1)

• Prognosis and immunotherapy tolerance in ESCC patients

  Follow-up for at least 1 year after undergoing surgery

Study Arms (1)

esophageal squamous cell carcinoma

Diagnostic Test: DNA Sequencing, RNA Sequencing

Interventions

DNA Sequencing, RNA Sequencing DIAGNOSTIC_TEST

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.

esophageal squamous cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

110 patients with ESCC in the Changhai hospital

You may qualify if:

• 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.
• The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.

You may not qualify if:

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

Sponsors & Collaborators

• Wangluowei: lead

Study Sites (1)

Changhai hospital

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

110 cases of esophageal squamous cell carcinoma patients. The data types include: ① H\&E stained images: These atlases display the morphology and tissue structure of cells through the staining of tissue sections, providing important morphological information for disease research. ② Molecular data: Molecular information obtained using NanoString technology reveals changes in gene expression, providing a data foundation for the study of the molecular mechanisms of the disease.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Luowei Wang

  Changhai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., PhD., Doctoral supervisor, Professor, Chief physician

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 13, 2024
• Study Start: June 13, 2018
• Primary Completion: October 21, 2022
• Study Completion: October 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)