Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center

This study is a multi-center observational study. The start time for data collection is August 31, 2019. Patients who have been treated at our institution from August 31, 2019, who were diagnosed with pancreatic tumors on or before August 31, 2019 (diagnosed in our hospital or outside hospitals) would all meet the inclusion conditions of the study and be considered enrollment. Patients' baseline and treatment data will be collected under informed concent. The combination of medical big data governance and the leading technology of the big data platform uses real world data to improve the quality and efficiency of pancreatic tumor diagnosis, treatment and scientific research.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Other: No intervention will be considered in this study.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenjiH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed as tumor of pancreas will all be considered for enrollment.

Description

Inclusion Criteria:

1. Age ≥ 18, both male and female;
2. Patients with primary pancreatic tumor diagnosed by histology, cytology or imaging;
3. Clinical or pathological staging is locally advanced or metastatic pancreatic tumor (newly diagnosed or after surgery and other treatments);
4. You can accept or have not received surgery, chemotherapy, radiotherapy, local treatment or traditional Chinese medicine for tumors;
5. The subject voluntarily joined the study and signed an informed consent form voluntarily.

Exclusion Criteria:

1. Pancreatic tumors are evaluated as metastatic lesions, not primary tumors of the pancreas.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm; Patients diagnosed as pancreatic tumor will considered to be enrolled regardless of specific pathologic subtypes expect for metastasis of pancreas. Baseline data and treatment information will be collected under fully informed consent.	Other: No intervention will be considered in this study.; No intervention will be considered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	disease free survival	5 years
PFS	progress free survival	5 years

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2019
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: November 20, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 20, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CPOG-CDPC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No