No interventions
OtherAll 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.
NCT Number: NCT06822413
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.
Interested in participating?
Request InfoAll sexes
Observational
The First Affiliated Hospital to Nanchang University, Nanchang, Jiangxi, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From patient enrollment to the completion of model construction, expected to be finalized within two months after data collection.
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.
Time frame: From the end of model construction to the end of model interpretable analysis - expected 2 months after model construction
Performing interpretable analysis of the diagnosis derived from the primary outcome using Grad-CAM to visualize and illustrate the model's decision-making process.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
A Novel Raman Spectroscopy-Based Method for Pan-Cancers Early Diagnosis Supported by Deep Learning: A Prospective, Single-Arm, Multicentre Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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