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NCT Number: NCT07670286

Spatial Multi-omics and Intelligent Early Warning of Pancreatic Cancer Cachexia

The goal of this observational study is to explore the spatial multi-omics mechanism of cachexia in pancreatic cancer and construct a high-precision multimodal intelligent early warning model for its early diagnosis in pathologically confirmed pancreatic ductal adenocarcinoma patients aged ≥18 years with an expected survival of ≥1 month.

The main questions it aims to answer are: 1) Can spatial transcriptomics/metabolomics reveal the interaction mechanism between tumor microenvironment and metabolism in pancreatic cancer cachexia? 2)Can a multimodal AI early warning model be built to achieve accurate early identification of pancreatic cancer cachexia? Researchers will compare the surgical cohort and advanced cohort to see the differences in cachexia incidence and progression rules among different subgroups. Participants will complete baseline questionnaires on physical and mental state, nutrition and muscle strength, undergo imaging examinations and provide biological samples (blood, feces, tissue etc.), and receive regular follow-ups for updated questionnaires, imaging rechecks and supplementary biological sample collection until death, loss to follow-up or voluntary withdrawal.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with pathologically confirmed pancreatic ductal adenocarcinoma.
  • Aged ≥18 years with an expected survival time of ≥1 month (to be assessed for the advanced cohort). Assessment criteria: Comprehensive evaluation based on the patient's radiological tumor burden, vital organ function and physical status. Specific quantitative indicators: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, or Karnofsky Performance Status (KPS) score of ≥60. For patients in the advanced cohort, the assessment shall be jointly confirmed by two attending physicians with the professional title of associate chief physician or above in combination with radiological examination results.
  • Voluntarily sign the informed consent form.

Exclusion criteria

  • Complicated with other untreated malignant tumors or severe mental disorders.
  • Pregnant women or patients unable to cooperate with follow-up.

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: Time from enrollment to all-cause death, assessed up to 3 years.

Secondary outcomes

  1. Cachexia-free survival

    Time frame: Time from enrollment to cachexia diagnosis, assessed up to 3 years.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Spatial Multi-omics Mechanism Analysis and Multimodal Intelligent Early Warning of Cachexia in Pancreatic Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 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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