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

NCT07670286 | Recruiting

• 1 other identifier: SMIPC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Cachexia; Cancer; Sarcopenia

Keywords

Spatial Multi-omics; Multimodal intelligent; Pancreatic Cancer; Cachexia

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

Secondary Outcomes (1)

• Cachexia-free survival

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

Study Arms (2)

Resectable group

Patients is resectable and received surgery

Unresectable group

Patients is unresectable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically confirmed pancreatic ductal adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and tissues

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 26, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-04

Locations

CN (1)