- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670286
Spatial Multi-omics and Intelligent Early Warning of Pancreatic Cancer Cachexia
Spatial Multi-omics Mechanism Analysis and Multimodal Intelligent Early Warning of Cachexia in Pancreatic Cancer
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Ruizhe Zhu
- Phone Number: +86 17896014778
- Email: zhuruizhe@pumch.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Resectable group
Patients is resectable and received surgery
|
|
Unresectable group
Patients is unresectable
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: Time from enrollment to all-cause death, assessed up to 3 years.
|
Time from enrollment to all-cause death, assessed up to 3 years.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cachexia-free survival
Time Frame: Time from enrollment to cachexia diagnosis, assessed up to 3 years.
|
Time from enrollment to cachexia diagnosis, assessed up to 3 years.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Endocrine System Diseases
- Nervous System Diseases
- Neuromuscular Manifestations
- Neoplasms by Site
- Pathological Conditions, Anatomical
- Body Weight
- Body Weight Changes
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Muscular Atrophy
- Atrophy
- Weight Loss
- Thinness
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neoplasms
- Pancreatic Neoplasms
- Sarcopenia
- Cachexia
Other Study ID Numbers
- SMIPC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
City of Hope Medical CenterRecruitingPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Resectable | Pancreatic Carcinoma | Pancreatic Cancer Non-resectable | Pancreatic Cancer Stage III | Pancreatic Cancer Stage | Pancreatic Cancer Stage II | Pancreatic Cancer, Adult | Pancreatic... and other conditionsUnited States, Japan, South Korea
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
The First Affiliated Hospital with Nanjing Medical...Peking University Cancer Hospital & InstituteNot yet recruiting
-
Tianjin Medical University Cancer Institute and...Not yet recruiting
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of UtahNovartis Pharmaceuticals; Huntsman Cancer InstituteTerminatedMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingPancreatic Neoplasms | Pancreas Adenocarcinoma | Pancreatic Cancer Resectable | Cancer of Pancreas | Pancreatic Cancer Non-resectable | Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Cancer, AdultUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States