Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.

November 15, 2021 updated by: Yang Jin, Wuhan Union Hospital, China

Research and Development of an Artificial Intelligence Technology System for Digital Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.

To improve accurate diagnosis and treatment of common malignant tumors and major infectious diseases in the respiratory system, we aim to establish a large medical database that includes standardized and structured clinical diagnosis and treatment information such as electronic medical records, image features, pathological features, and multi-omics information, and to develop a multi-modal data fusion-based technology system for individualized intelligent pathological diagnosis and therapeutic effect prediction using artificial intelligence technology.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The main aims are as follows:

  1. To establish a medical big data platform for multi-modal information fusion of common tumors and major infectious diseases (lung cancer/pulmonary nodules, tuberculosis, and COVID-19) based on the existing pathological image features and clinical multi-omics information database: The medical big data platform supports the acquisition of the patient's clinical electronic medical records (including routine clinical detection), full view digital section of pathological image data, medical imaging (CT, MRI, ultrasound, nuclear medicine, etc.), multiple omics data (genome, transcriptome, and metabolome, proteomics) omics data, etiology, pathology, and associated graphic data reports and multimodal medical treatment data. We aim to realize the storage, sharing, fusion computing, privacy protection, and security supervision of multi-modal and cross-scale biomedical big data. Our work will open up key business processes and links across regions, across hospitals, between different terminals, between hospitals and doctors, and between departments, so as to promote continuous data accumulation and knowledge precipitation in hospitals and promote medical collaboration.
  2. To create a multimodal information fusion database with pathologic features, imaging features, multi-omics (pathologic, genomic, transcriptome, metabolome, proteomics, etc.), and clinical information of patients at different stages of lung cancer/pulmonary nodules, tuberculosis, and COVID-19. The database scale includes multimodal data of at least 600 lung cancer/pulmonary nodules, 200 tuberculosis, and 200 COVID-19 patients. Moreover, there will be more than 10 biomarkers significantly related to the diagnosis and treatment of patients with lung cancer/pulmonary nodules, tuberculosis and COVID-19 were excavated through association analysis, providing parameters for artificial intelligence model construction.
  3. We will make use of artificial intelligence technology to create the multi-modal medical big data cross-analysis technology and the above disease individualized accurate diagnosis and curative effect prediction models. In order to solve the three key problems of multi-modal data fusion mining, such as unbalanced, small sample size, and poor interpretability, we will establish an ARTIFICIAL intelligence recognition algorithm for image images and pathological images, and use image processing and deep learning technologies to mine multi-level depth visual features of image data and pathological data. In addition, we will use bioinformatics analysis algorithms to conduct molecular network mining and functional analysis of molecular markers at the level of multiple omics technologies (pathologic, genomic, transcriptome, metabolome, proteome, etc.).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Common malignant tumors and major infectious diseases in lung, including lung cancer, pulmonary tuberculosis, and COVID-19.

Description

Inclusion Criteria:

  1. Participants with the clinical diagnosis of lung cancer, pulmonary tuberculosis, and COVID-19.
  2. Participants that have signed informed consent.
  3. Participants >= 18 years old and < 90 years old.
  4. Participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information.
  5. Healthy participants with no clinical diagnosis of lung cancer, pulmonary tuberculosis, and COVID-19.

Exclusion Criteria:

  1. Participants < 18 years old.
  2. Participants with primary clinical and pathological data missing.
  3. Participants lost to follow-up.
  4. Participants with too poor medical image quality to perform segment and mark ROI accurately.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Lung cancer group
Participants with lung cancer/pulmonary nodules
Pulmonary tuberculosis group
Participants with pulmonary tuberculosis
COIVD-19 group
Participants with COIVD-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The outcome of clinical diagnosis of suspected patients with lung cancer/pulmonary nodular (Benign/Malignant nodule).
Time Frame: 2021-2024

The outcome of clinical diagnosis of patients with lung cancer/pulmonary nodular (Benign/Malignant nodule).

① Benign nodule

② Malignant neoplasm/nodule: squamous cell carcinoma, adenocarcinoma, small cell carcinoma, and large cell carcinoma.

2021-2024
The outcome of clinical diagnosis of suspected patients with pulmonary tuberculosis (Positive/Negative).
Time Frame: 2021-2024
The outcome of clinical diagnosis of patients with pulmonary tuberculosis (Positive/Negative).
2021-2024
The outcome of clinical diagnosis of suspected patients with COVID-19 (Positive/Negative).
Time Frame: 2021-2024
The outcome of clinical diagnosis of patients with COVID-19 (Positive/Negative).
2021-2024
Treatment response of anti-cancer therapy at first evaluation in patients with lung cancer/pulmonary nodules (CR, PR, PD, SD).
Time Frame: 2021-2024

The treatment response of anti-cancer therapy at first evaluation in patients with lung cancer/pulmonary nodules follows The Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) from the World Health Organization (WHO). The evaluation index is as follows.

CR (complete response): Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm.

PR (partial response): 30% decrease in the sum of the longest diameter of the target lesions compared with baseline.

PD (progressive disease):≥20% increase of at least 5 mm in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded OR The appearance of new lesions, including those detected by FDG-PET (fludeoxyglucose positron emission tomography).

SD (stable disease): Neither PR nor PD.

2021-2024
Treatment response of anti-inflammation and antiviral therapy at first evaluation in patients with COVID-19 (effective/ineffective treatment).
Time Frame: 2021-2024

Treatment response of anti-inflammation and antiviral therapy at first evaluation in patients with COVID-19 (effective/ineffective treatment).

effective treatment: Improved total time to recovery, resolution of fever, cough remission, and pneumonia severity.

ineffective treatment: The above conditions have not improved or patients go die.

2021-2024
Treatment response of antituberculous bacilli and anti-inflammation therapy at first evaluation in patients with pulmonary tuberculosis.
Time Frame: 2021-2024

Treatment cure: patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion.

Treatment completer: patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative.

Treatment success: The sum of cured and treatment completed.

Treatment failure: patients whose sputum smear or culture is positive at month 5 or later during treatment.

Treatment relapse: Patients who were declared cured or treatment completed at the end of their most recent course of TB treatment, and are now diagnosed with a recurrent episode of TB. This can be either a true relapse or a new episode of TB caused by reinfection.

Patient died.

2021-2024
Progression free survival
Time Frame: 2021-2024
The time interval between the date of treatment initiation and disease progression (Months) of patients with lung cancer/pulmonary nodules.
2021-2024
Overall survival
Time Frame: 2021-2024
The time interval between the date of diagnosis and death (Months) of patients with lung cancer/pulmonary nodules.
2021-2024
Whole genome sequencing of blood samples
Time Frame: 2021-2024
Whole-genome sequencing of blood samples before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Whole-genome sequencing is mainly used to find single nucleotide polymorphisms (SNPs), copy number variations, and insertions/deletions.
2021-2024
Whole-genome sequencing of tissue samples
Time Frame: 2021-2024
Whole-genome sequencing of tissue samples after surgery in patients with lung cancer/pulmonary nodular and tuberculosis. Whole-genome sequencing is mainly used to find single nucleotide polymorphisms (SNPs), copy number variations, and insertions/deletions.
2021-2024
Whole genome sequencing of exhaled air condensate samples
Time Frame: 2021-2024
Whole-genome sequencing of exhaled air condensate samples before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Whole-genome sequencing is mainly used to find single nucleotide polymorphisms (SNPs), copy number variations, and insertions/deletions.
2021-2024
Whole genome sequencing of urine samples
Time Frame: 2021-2024
Whole-genome sequencing of urine specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Whole-genome sequencing is mainly used to find single nucleotide polymorphisms (SNPs), copy number variations, and insertions/deletions.
2021-2024
Transcriptome sequencing of blood samples
Time Frame: 2021-2024
Transcriptome sequencing of blood samples before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. The collection of all transcripts, including messenger RNA, ribosomal RNA, transport RNA, and non-coding RNA.
2021-2024
Transcriptome sequencing of tissue samples
Time Frame: 2021-2024
Transcriptome sequencing of tissue samples after surgery in patients with lung cancer/pulmonary nodular and tuberculosis. The collection of all transcripts, including messenger RNA, ribosomal RNA, transport RNA, and non-coding RNA.
2021-2024
Transcriptome sequencing of exhaled air condensate samples
Time Frame: 2021-2024
Transcriptome sequencing of exhaled air condensate specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. The collection of all transcripts, including messenger RNA, ribosomal RNA, transport RNA, and non-coding RNA.
2021-2024
Transcriptome sequencing of urine samples
Time Frame: 2021-2024
Transcriptome sequencing of urine specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. The collection of all transcripts, including messenger RNA, ribosomal RNA, transport RNA, and non-coding RNA.
2021-2024
Metabolomics of blood samples
Time Frame: 2021-2024
Metabolomics of blood specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Non-target metabolites are generally analyzed qualitatively and quantitatively based on LC-MS technology for metabolites in samples, and identified by matching primary and secondary information with local self-built databases and commercial standard databases.
2021-2024
Metabolomics of tissue samples
Time Frame: 2021-2024
Metabolomics of tissue samples after surgery in patients with lung cancer/pulmonary nodular and tuberculosis. Non-target metabolites are generally analyzed qualitatively and quantitatively based on LC-MS technology for metabolites in samples, and identified by matching primary and secondary information with local self-built databases and commercial standard databases.
2021-2024
Metabolomics of exhaled air condensate samples
Time Frame: 2021-2024
Metabolomics of exhaled air condensate specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Non-target metabolites are generally analyzed qualitatively and quantitatively based on LC-MS technology for metabolites in samples, and identified by matching primary and secondary information with local self-built databases and commercial standard databases.
2021-2024
Metabolomics of urine samples
Time Frame: 2021-2024
Metabolomics of urine specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Non-target metabolites are generally analyzed qualitatively and quantitatively based on LC-MS technology for metabolites in samples, and identified by matching primary and secondary information with local self-built databases and commercial standard databases.
2021-2024
Proteomics of blood samples
Time Frame: 2021-2024
Proteomics of blood specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Unlabeled proteomics technology based on the timsTOF Pro ion mobility platform for differential quantitative proteomics analysis using data-dependent acquisition - Synchronous cumulative continuous fragmentation (ddaPASEF) scan mode.
2021-2024
Proteomics of tissue samples
Time Frame: 2021-2024
Proteomicstissue samples after surgery in patients with lung cancer/pulmonary nodular and tuberculosis. Unlabeled proteomics technology based on the timsTOF Pro ion mobility platform for differential quantitative proteomics analysis using data-dependent acquisition - Synchronous cumulative continuous fragmentation (ddaPASEF) scan mode.
2021-2024
Proteomics of exhaled air condensate samples
Time Frame: 2021-2024
Proteomics of exhaled air condensate specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Unlabeled proteomics technology based on the timsTOF Pro ion mobility platform for differential quantitative proteomics analysis using data-dependent acquisition - Synchronous cumulative continuous fragmentation (ddaPASEF) scan mode.
2021-2024
Proteomics of urine samples
Time Frame: 2021-2024
Proteomics of urine specimens before and after treatment in patients with lung cancer/pulmonary nodular, tuberculosis, and COVID-19. Unlabeled proteomics technology based on the timsTOF Pro ion mobility platform for differential quantitative proteomics analysis using data-dependent acquisition - Synchronous cumulative continuous fragmentation (ddaPASEF) scan mode.
2021-2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sex (male/female)
Time Frame: 2021-2024
sex of patients(male/female).
2021-2024
age (years)
Time Frame: 2021-2024
age of patients (years).
2021-2024
weight (kilograms)
Time Frame: 2021-2024
weight of patients (kilograms)
2021-2024
height (meters)
Time Frame: 2021-2024
height of patients (meters).
2021-2024
heart rate in each minute
Time Frame: 2021-2024
heart rate in each minute of patients.
2021-2024
blood pressure (mmHg)
Time Frame: 2021-2024
blood pressure (mmHg) of patients.
2021-2024
Forced vital capacity (FVC)
Time Frame: 2021-2024
Forced vital capacity (FVC) of patients
2021-2024
forced expiratory volume in one second (FEV1)
Time Frame: 2021-2024
forced expiratory volume in one second (FEV1) for lung volume
2021-2024
peak expiratory flow (PEF)
Time Frame: 2021-2024
peak expiratory flow (PEF) for velocity
2021-2024
carbon monoxide diffusion capacity (DLCO)
Time Frame: 2021-2024
carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.
2021-2024
St. George's Respiratory Questionnaire(SGRQ)
Time Frame: 2021-2024
St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.
2021-2024
C-reactive protein in blood(mg/L)
Time Frame: 2021-2024
C-reactive protein (mg/L)
2021-2024
total protein in blood(umol/L)
Time Frame: 2021-2024
total protein(umol/L)
2021-2024
aspartate aminotransferase in blood(U/L)
Time Frame: 2021-2024
aspartate aminotransferase (U/L)
2021-2024
glutamic-pyruvic transaminase in blood(U/L)
Time Frame: 2021-2024
glutamic-pyruvic transaminase (U/L)
2021-2024
D-dimer in blood(ug/L)
Time Frame: 2021-2024
D-dimer (ug/L)
2021-2024
fibrinogen in blood(g/L)
Time Frame: 2021-2024
fibrinogen(g/L)
2021-2024
Active part thrombin time in blood(APTT)
Time Frame: 2021-2024
Active part thrombin time (APTT)
2021-2024
prothrombin time in blood(PT)
Time Frame: 2021-2024
prothrombin time (PT)
2021-2024
thrombin time in blood (TT)
Time Frame: 2021-2024
thrombin time (TT).
2021-2024
leucocytes in blood(×109/L)
Time Frame: 2021-2024
leucocytes(×109/L)
2021-2024
neutrophils in blood(×109/L)
Time Frame: 2021-2024
neutrophils in blood(×109/L)
2021-2024
lymphocytes in blood(×109/L)
Time Frame: 2021-2024
lymphocytes in blood(×109/L)
2021-2024
monocytes in blood(×109/L)
Time Frame: 2021-2024
monocytes in the blood(×109/L)
2021-2024
eosinophils in the blood(×109/L)
Time Frame: 2021-2024
eosinophils in the blood(×109/L)
2021-2024
platelets in the blood(×109/L)
Time Frame: 2021-2024
platelets in the blood(×109/L)
2021-2024
Carcinoembryonic Antigen (ug/L)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Cytokeratin 19 fragment (ug/L)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Squamous Cell Carcinoma Antigen(ug/L)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Nervous specific enolase (U/mL)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Tissue Polypeptide Specific Antigen(ug/L)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Cancer antigen 125 (U/mL)
Time Frame: 2021-2024
Serum tumor markers including Carcinoembryonic Antigen (ug/L), Cytokeratin 19 fragment , Squamous Cell Carcinoma Antigen(ug/L), Nervous specific enolase (U/mL), Tissue Polypeptide Specific Antigen(ug/L), Cancer antigen 125 (U/mL), Cancer antigen 15-3 (U/mL), Bombesin (U/mL), The stomach secrete ty (U/mL), β2-microglobulin (U/mL).
2021-2024
Cancer antigen 15-3 (U/mL)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
Bombesin (U/mL)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
β2-microglobulin (U/mL)
Time Frame: 2021-2024
Serum tumor marker
2021-2024
the outcome of Etiological detection
Time Frame: 2021-2024
Etiological detection including Mycoplasma, Chlamydia, Viruses, Bacteria (especially Mycobacterium tuberculosis), and Fungi. (Positive/Negative)
2021-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Yang Jin, Professor, union hospital, Tongji Medical college, Huazhonguniversity of science and technology

Study record dates

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 Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • [2021]IEC(491)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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