Development and Demonstration of Intelligent Assessment Based on Multi-modal Information Fusion for Tumor Risk and Diagnosis and Treatment

NCT06653478 | Recruiting

• 1 other identifier: Jin-BT&IT
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

To improve the accuracy of risk prediction, screening and treatment outcome of cancer, we aim to establish a medical database that includes standardized and structured clinical diagnosis and treatment information, image features, pathological features, and multi-omics information and to develop a multi-modal data fusion-based technology system using artificial intelligence technology based on database.

Conditions

Artificial Intelligence; Deep Learning; Lung Cancer; Lung; Node; Stomach Cancer; Colon Cancer; Cancer Risk; Cancer Screening; Cancer, Treatment-Related

Outcome Measures

Primary Outcomes (3)

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

  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.

  2022-2026

• The outcome of clinical diagnosis of suspected patients with colorectal cancer or lesion (Benign/Malignant).

  ① Benign ② Malignant

  2022-2026

• Treatment response of anti-cancer therapy at first evaluation in patients with lung/stomach/colorectal cancer (CR, PR, PD, SD).

  The treatment response of anti-cancer therapy at first evaluation in patients with lung/stomach/colorectal cancer 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.

  2022-2026

Study Arms (3)

Lung cancer group

Participants with lung cancer/pulmonary nodules

Other: No Intervention

Stomach cancer group

Participants with Stomach cancer/Stomach lesion

Other: No Intervention

Colorectal cancer group

Participants with Colorectal cancer/Colorectal lesion

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Colorectal cancer group; Lung cancer group; Stomach cancer group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients the suspected of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision

You may qualify if:

• Participants with the suspected of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision
• Participants that have signed informed consent.
• Participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information.
• Healthy participants with no clinical diagnosis of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision.

You may not qualify if:

• Participants with primary clinical and pathological data missing.
• Participants lost to follow-up.
• Participants with too poor medical image quality to perform segment and mark ROI accurately

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Stomach Neoplasms; Colonic Neoplasms; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Study Officials

• Yang Jin

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanjuan Xu

CONTACT

+86 15827125538; whuhjy@126.com

Yang Jin

CONTACT

Study Design

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

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: June 1, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-09

Locations

CN (1)