Construction and Clinical Application of the Immune Map of Pancreatic Cancer Evolution

NCT ID: NCT07034339

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2027-12-31

Brief Summary

The intricate interplay between systemic immunity and tumors profoundly influences not only the onset and progression of tumors but also serves as a crucial window into understanding tumor evolution and treatment status. This project aims to establish a large, multi-center pancreatic cancer cohort and a standardized clinical sample repository, capturing multimodal immunity big data on pancreatic cancer occurrence, progression, and treatment response across the spatial dimension of "peripheral versus local" and the temporal dimension of "tumor evolution/pre- and post-treatment." By integrating patient imaging and clinical information, the investigators will develop a technical platform for intelligent extraction and fusion analysis of cross-scale, multimodal data, thereby mapping the immunity landscape of pancreatic cancer evolution, identifying characteristic changes in immunity parameters, and devising an AI model for early pancreatic cancer diagnosis with high accuracy and robust generalization capabilities, while also exploring the model's interpretability. Additionally, the investigators will focus on specific immune cell subsets associated with pancreatic cancer evolution and treatment response, elucidating their roles and mechanisms in the occurrence, development, and drug resistance of pancreatic cancer. This project will establish a high-quality, standardized, and shareable pancreatic cancer immunity sample and data repository, refine the framework for multi-dimensional immunity data fusion and analysis, and create a time-space atlas of local and systemic immunity in pancreatic cancer. This will facilitate a deeper understanding of the dynamics of systemic and local immunity in early-stage pancreatic cancer and at various stages of its evolution, offering novel insights and approaches for the diagnosis and treatment of pancreatic cancer.

Conditions

Immune Evasion, Tumor; Pancreas Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional treatment queue

No interventions assigned to this group

Dynamic follow-up queue

No interventions assigned to this group

Neoadjuvant therapy queue

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Healthy individuals without benign or malignant liver, gallbladder, and pancreas diseases
• Primary PDAC
• Patients with benign pancreatic tumors
• IPMN patients diagnosed by pathology/imaging

Exclusion Criteria

• Having autoimmune diseases
• Accompanied by other malignant tumors
• History of tumor treatment (except thyroid cancer and breast cancer, cured for more than 5 years)
• Acute infection
• History of blood transfusion within the past 6 months, or use of drugs that affect peripheral blood components such as recombinant human erythropoietin and interleukin within 2 weeks
• Organ decompensation dysfunction
• Immunodeficiency syndrome
• Hematological precancerous lesions
• Accept immunosuppressive therapy
• Diagnosed coagulation disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qi Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yangyang Wang

Role: CONTACT

12418635@zju.edu.cn

13957830918

Facility Contacts

Yangyang Wang, Doctor

Role: primary

12418635@zju.edu.cn

13957830918

Other Identifiers

IDPEPDAC

Identifier Type: -

Identifier Source: org_study_id