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NCT Number: NCT07616011

Artificial Intelligence-Based Early Warning for Distant Metastasis in Malignant Tumors

Early detection and timely intervention of distant metastasis are essential for improving the prognosis of patients with malignant tumors. However, current clinical methods have notable limitations. Conventional imaging can only detect macroscopic metastatic lesions, failing to seize the optimal intervention window before metastasis occurs or during the micrometastasis stage. Previous research has adopted artificial intelligence to break the constraints of traditional imaging and realized subclinical early warning of distant metastasis based on retrospective data. On this basis, the present study aims to systematically validate the predictive performance and generalizability of the model in real-world clinical settings via a prospective cohort. This study intends to establish an organ-specific, non-invasive and cost-effective pan-cancer tool for early warning of distant metastasis. It can gain critical time for clinical intervention, help reduce the incidence of distant metastasis and ultimately optimize patient prognosis.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years old;
  • Diagnosed with malignant tumor confirmed by histopathology;
  • No distant metastasis detected at baseline enrollment assessment;
  • Regular imaging examinations for distant metastasis assessment are scheduled in the routine follow-up protocol after enrollment;
  • Complete baseline clinicopathological data are available;
  • Patients provide informed consent and permit researchers to collect and analyze their subsequent imaging and clinicopathological data.

Exclusion criteria

  • Concurrent presence of two or more primary malignant tumors;
  • Presence of any medical or social factors that may interfere with completion of routine imaging follow-up.

Treatment and study plan

Primary outcomes

  1. Incidence of distant metastasis

    Time frame: At each routine follow-up visit (interval: approximately 6 months to 1 year)

    Proportion of patients with distant metastasis among malignant tumor cases

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
May 29, 2026
Registry last updated
May 29, 2026

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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