Raman Spectroscopy-Based Deep Learning Model for Early Pan-Cancer Early Diagnosis

NCT06822413 | Recruiting

• 1 other identifier: 2024-1060
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this observational study is to explore whether a Raman-based, deep learning-assisted approach can be used to develop an effective method for early pan-cancer screening. The study includes healthy individuals, patients at risk of cancer, and patients with diagnosed cancers. The main questions it aims to answer are:

• Evaluating the deep-learning model's accuracy and specificity in identifying cancer-specific features in Raman spectral data and determining whether this method can accurately classify patients based on risk.
• Identifying which model is more adaptable to the Raman spectrum
• Providing an interpretable analysis of the model-generated diagnosis Participants are already being diagnosed and follow-up to determine the type of cancer.

Conditions

Cancer Diagnosis; Liver Cancer, Adult; Cancer Screening; Colorectal Cancer (CRC); Gastric Cancers; Normal Physiology; Pancreatic Cancer, Adult; Raman Spectroscopy; Deep Learning Model; Esophageal Cancer; Malignant Tumours; Precancerous Conditions; Pancreatitis; Adenoma Colon Polyp; Gastric Ulcer; Oesophagitis; Cirrhoses, Liver

Keywords

Pan-cancer; Deep Learning Models; Cancer Screening; Raman Spectroscopy; Colorectal Cancer; Pancreatic Cancer; Gastric Cancer; Esophageal Cancer; malignant tumour; Precancerous Condtions; Pancreatitis; Colorectal Adenoma; Gastirc Ulcer; Oesophagitis; Cirrhoses

Outcome Measures

Primary Outcomes (1)

• A Deep Learning Model for High-Accuracy Pan-Cancer Classification

  Establish deep learning models with high specificity and sensitivity for pan-cancer classification, capable of distinguishing different pan-cancer types (Distinguish between patients in physiological conditions, precancerous lesion and malignant tumour) based on Raman spectroscopy.

  From patient enrollment to the completion of model construction, expected to be finalized within two months after data collection.

Secondary Outcomes (1)

• Raman Shift Characteristics for Model Decision Interpretation and Visualization

  From the end of model construction to the end of model interpretable analysis - expected 2 months after model construction

Study Arms (11)

Normal Physiology

Patients without cancers or precancerous lesion

Other: No Interventions

Colorectal Cancer

Patients diagnosed with colorectal cancer (Pre-intervention)

Other: No Interventions

Gastric Cancer

Patients diagnosed with gastric cancer (Pre-intervention)

Other: No Interventions

Hepatic Cancer

Patients diagnosed with hepatic cancer (Pre-intervention)

Other: No Interventions

Oesophageal

Patients diagnosed with oesophageal cancer (Pre-intervention)

Pancreatic Cancer

Patients diagnosed with pancreatic cancer (Pre-intervention)

Other: No Interventions

Gastric Ulcer

Patients with gastric ulcers without any cancer

Other: No Interventions

Colorectal Adenoma

Patients with colorectal adenoma without any cancer

Other: No Interventions

Liver Cirrhosis

Patients with liver cirrhosis without any cancer

Other: No Interventions

Pancreatitis

Patients with pancreatitis without any cancer

Other: No Interventions

Oesophagitis

Patients with oesophagitis without any cancer

Other: No Interventions

Interventions

No Interventions OTHER

All blood samples from participating patients were obtained from routine clinical blood tests conducted during hospital admission or other necessary medical evaluations, followed by serum extraction.

Colorectal Adenoma; Colorectal Cancer; Gastric Cancer; Gastric Ulcer; Hepatic Cancer; Liver Cirrhosis; Normal Physiology; Oesophagitis; Pancreatic Cancer; Pancreatitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pan-cancer patients from Zhejiang, Jiangxi and Shanghai province

You may qualify if:

• Histopathological diagnosis of malignant tumors, including colorectal cancer, gastric cancer, hepatic cancer, pancreatic cancer, and esophageal cancer.
• Patients in normal physiological conditions without any malignant tumors or precancerous lesions.
• Patients with malignant tumor without recieving any interventions, including chemotherapy, surgery, radiotherapy, immunotherapy or other anti-tumor treatments.
• Patients with a histopathological diagnosis of any precancerous lesions or non-malignant disease.

You may not qualify if:

• Patients with metastatic tumors or in the condition with two or more kinds of malignant tumors at the same time
• Post-cancer treatment patients.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Huashan Hospital: collaborator

Study Sites (4)

The First Affiliated Hospital to Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The Second Affiliated Hospital to Nanchang University

Nanchang, Jiangxi, 330008, China

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Stomach Neoplasms; Pancreatic cancer, adult; Esophageal Neoplasms; Neoplasms; Precancerous Conditions; Pancreatitis; Stomach Ulcer; Esophagitis; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pancreatic Diseases; Peptic Ulcer; Duodenal Diseases; Gastroenteritis; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Kefeng Ding, MD

  Department of Colorectal Surgery, The Second Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jiasheng Xu, MD

CONTACT

+86 18720996980; 1821286450@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: September 1, 2022
• Primary Completion: May 15, 2025
• Study Completion: July 28, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)