NCT07034339

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
May 2025Dec 2027

Study Start

First participant enrolled

May 21, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

June 15, 2025

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pancreatic tumor resection

    Number of participants with pancreatic cancer

    3 years

Study Arms (3)

Conventional treatment queue

Dynamic follow-up queue

Neoadjuvant therapy queue

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with pancreatic cancer, benign diseases, and healthy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Yangyang Wang

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2025

First Posted

June 24, 2025

Study Start

May 21, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations