AI-Assisted Comprehensive Management for Cancer Patients With Comorbidities (GCOG-CG001)

NCT ID: NCT07136727

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2031-05-01

Brief Summary

Combined with the digital whole process management data pool, a multi-modal data fusion framework is developed, and an AI model is established to realize risk stratification and personalized treatment Recommendation and dynamic prognosis prediction; validation of whole-process management based on multimodal digital fusion AI-aided decision support system through prospective non-randomized controlled interventional study The effect on survival, complication control and utilization of medical resources in patients with comorbid malignant tumors.

Detailed Description

The title of this study is"The Impact of Multimodal Digital Fusion AI-Assisted Decision Support System-Based Comprehensive Management on Clinical Outcomes in County-Level Patients with Comorbid Cancer: A prospective non-randomized controlled interventional study", to evaluate the impact of full-course management based on a multimodal digital fusion AI-assisted decision support system on the clinical outcomes of county-level oncologic comorbid patients through a prospective non-randomized controlled interventional study. The study plans to enroll 5,000 patients with pathologically confirmed malignancies and at least one comorbid condition (diabetes, hypertension, etc.) , in the first stage, the epidemiological characteristics of co-morbidity and its impact on prognosis, treatment response and quality of life were analyzed In the second phase, patients with comorbid pulmonary malignancies were selected to compare the clinical effects of the voluntary whole-process management group (including personalized intervention such as nutritional screening and dynamic monitoring) and the conventional treatment group, the third stage integrates multi-center Electronic Medical Records, genomic data, wearable device monitoring and other multi-modal data to construct an AI decision-making system, developing risk stratification, personalized treatment recommendation, and dynamic prognostic prediction models, finally, the differences in core indicators such as survival rate (PFS, OS) , complication control and medical resource efficiency between AI-assisted management and traditional mode were compared. This study realizes the integrated intervention of in-hospital and out-of-hospital through digital whole-process management, which is expected to provide an AI-driven precise decision support paradigm for primary medical institutions and improve the efficiency of comprehensive management of tumor comorbidity.

Conditions

Oncological Comorbidities (e. g. Hypertension, Diabetes, Malnutrition)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AI management unit

For patients with comorbid pulmonary malignancies who have been included, the registration process is guided by the management platform. Researchers will use digital management throughout The platform carries out screening assessment and Comprehensive Evaluation of nutrition, exercise, psychology and symptoms of the subjects, and the system will be combined with the patient's disease and treatment Information, intelligent management of the whole project. The clinician can review the protocol in the light of the patient's disease status and give the full management instructions Case to patient side.

Group Type: EXPERIMENTAL

AI-assisted comprehensive management system

Intervention Type: OTHER

Precision Risk Stratification and personalized treatment recommendation through AI models may improve the suitability of treatment regimens and thus reduce the incidence of antineoplastic therapy-related adverse effects (e.g. , reduction of chemotherapy toxicity through nutritional intervention) , and improve the efficacy of chemotherapy, and prolonged progression-free survival (PFS) and overall survival (OS)

Standard Clinical Management

Patients who are not willing to accept the whole program will only be followed up, and will receive standard clinical management without AI-assisted digital platform support. Patients will receive conventional treatment. In the data analysis phase, subjects were stratified to explore the feasibility and effectiveness of digital whole-course management in patients with oncological comorbidities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AI-assisted comprehensive management system

Precision Risk Stratification and personalized treatment recommendation through AI models may improve the suitability of treatment regimens and thus reduce the incidence of antineoplastic therapy-related adverse effects (e.g. , reduction of chemotherapy toxicity through nutritional intervention) , and improve the efficacy of chemotherapy, and prolonged progression-free survival (PFS) and overall survival (OS)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a definite diagnosis of malignancy by histopathology and/or cytology;
• Age ≥18 years;
• There is no gender limit
• Plan to receive antineoplastic therapy within 2 weeks or are receiving standard antineoplastic care (surgery, radiation, chemotherapy, or targeted therapy) ;
• Conscious and able to answer questions and use electronic devices autonomously;
• Patients were able to understand the study and voluntarily sign an informed consent form;

Exclusion Criteria

• Having severe mental or cognitive impairments that prevent them from understanding the content of the study or implementing the programme;
• With severe heart disease, acute respiratory failure, liver kidney failure and other critical illness;
• Women during pregnancy or lactation；
• Have participated in other interventional studies in the past 1 month or are currently participating;
• Patients with ECOG ≥ 3 that do not respond to treatment;
• Patients with an expected survival of < 3 months that do not respond to treatment;
• Cases deemed unsuitable for enrollment by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xinxiang Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Shen Wei Shen, MD, Doctor of Medicine

Role: STUDY_CHAIR

First Affiliated Hospital of Xinjiang Medical University

Locations

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Countries

China

Central Contacts

Wei Shen Wei Shen, MD, Doctor of Medicine

Role: CONTACT

swccvsw@126.com

+86 15638800873

Ping Lu Ping Lu, MD, Doctor of Medicine

Role: CONTACT

lupingdoctor@126.com

+86 13598722864

Facility Contacts

Ping Lu Ping Lu, MD, Doctor of Medicine

Role: primary

lupingdoctor@126.com

+86 13598722864

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Other Identifiers

GCOG-CG001

Identifier Type: -

Identifier Source: org_study_id