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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xinxiang Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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) ;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted comprehensive management system

    Other intervention

    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)

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: AI management unitExperimental treatment 1 intervention
Group B: Standard Clinical ManagementNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) : the time from randomization (or study enrollment) to the observation of disease progression or the occurrence of death from any cause. This period was assessed every 6-8 weeks using RECIST 1.1 criteria.

Time frame
24 months
2

Overall survival (OS)

Overall survival (OS) : the time from study enrollment to death from any cause from any cause, every 3 months during treatment, and every 3 months after the end of treatment. The patients were followed up at 6 months and the cause of death was recorded.

Time frame
24 months

Secondary outcomes

1

Comorbidity control rate.

Comorbidity control rate: the proportion of comorbidities achieving guideline-recommended control targets during the study period; stratified criteria should be established based on specific comorbidity types.

Time frame
24 months
2

Quality of life(QLQ-C30).

Quality of life: changes in scores at baseline, on-treatment, and follow-up were assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 scale, between-group differences

Time frame
24 months
3

Medical resource consumption index.

Medical resource consumption index: Comparing DRG-adjusted medical resource consumption indices between two groups.

Time frame
24 months
4

Adherence to AI system interventions.

Adherence to AI Interventions: 1. In-Hospital Rate - Percentage of inpatients completing AI-recommended actions (e.g., nutritional screening, real-time monitoring). 2. Out-of-Hospital Completion Rate: Percentage of discharged/outpatients adhering to AI-guided care (e.g., telehealth, wearable data tracking). Enables precise evaluation of AI-driven care across clinical settings.

Time frame
24 months

Other outcomes

Sponsors and contacts

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