2022-09-01
2025-05-15
2025-07-28
600
NCT06822413
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
OBSERVATIONAL
Raman Spectroscopy-Based Deep Learning Model for Early Pan-Cancer Early Diagnosis
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.
This study aims to explore the use of deep learning models for classifying patients based on Raman spectroscopy analysis of blood samples, distinguishing between individuals in physiological conditions and patients with various types of precancerous conditions or malignant tumors. The study is conducted through a multi-center collaboration, where blood samples are collected from both healthy participants and patients with histopathologically diagnosed precancerous conditions or primary malignant tumors. All blood samples are obtained from patients' routine clinical blood tests conducted during hospital admission or other necessary medical evaluations. The spectral data undergo a rigorous preprocessing pipeline, which includes alignment resampling to standardize the data, baseline removal to eliminate unwanted variations, and normalization to ensure uniformity across all samples. The data is optimized for deep learning model training. Various deep-learning models are then employed to analyze the processed Raman spectra and develop a classification system to distinguish between pan-cancer cases and healthy controls. The preprocessed dataset is partitioned into three subsets for model training and performance evaluation: 80% for training, 10% for validation, and 10% for testing. These datasets are used for model training to identify patterns in the spectral data that correlate with the presence of specific cancers or a healthy state, enabling accurate classification. To enhance the interpretability of deep learning models, Grad-CAM (Gradient-weighted Class Activation Mapping) is used to visualize the models' decision-making processes. This allows the identification of the Raman spectra regions that are more influential in the model's classification decision, providing a transparent understanding of how the model differentiates between the various classes. Ultimately, this study aims to demonstrate the potential of Raman spectroscopy combined with deep learning techniques as a non-invasive, accurate, and interpretable method for cancer detection and classification, with implications for early diagnosis and personalized treatment strategies.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2025-02-05 | N/A | 2025-04-19 |
2025-02-05 | N/A | 2025-04-24 |
2025-02-12 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
: Normal Physiology Patients without cancers or precancerous lesion | OTHER: No Interventions
|
: Colorectal Cancer Patients diagnosed with colorectal cancer (Pre-intervention) | OTHER: No Interventions
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: Gastric Cancer Patients diagnosed with gastric cancer (Pre-intervention) | OTHER: No Interventions
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: 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
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 Outcome Measures | Measure Description | Time Frame |
---|---|---|
Raman Shift Characteristics for Model Decision Interpretation and Visualization | Performing interpretable analysis of the diagnosis derived from the primary outcome using Grad-CAM to visualize and illustrate the model's decision-making process. | From the end of model construction to the end of model interpretable analysis - expected 2 months after model construction |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Jiasheng Xu, MD Phone Number: +86 18720996980 Email: 1821286450@qq.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available