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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05141656
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Anticipated Duration (Months): 47
• Patients Per Site Per Month: 425.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Other: No intervention will be considered in this study.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
• Actual Study Start Date: Aug 31, 2019
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. OS [5 years]

   overall survival

Secondary Outcome Measures

1. DFS [5 years]

   disease free survival

2. PFS [5 years]

   progress free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RenJiH	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT05141656
• Other Study ID Numbers: CPOG-CDPC-01
• First Posted: Dec 2, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Dec 2, 2021