Pancreatic NeoplasmsNCT05141656
Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
An observational study of Pancreatic Neoplasms, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Neoplasms
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2019to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as tumor of pancreas will all be considered for enrollment.
Who may be able to join
- Age ≥ 18, both male and female;
- Patients with primary pancreatic tumor diagnosed by histology, cytology or imaging;
- Clinical or pathological staging is locally advanced or metastatic pancreatic tumor (newly diagnosed or after surgery and other treatments);
- You can accept or have not received surgery, chemotherapy, radiotherapy, local treatment or traditional Chinese medicine for tumors;
- The subject voluntarily joined the study and signed an informed consent form voluntarily.
Who cannot join
- 1. Pancreatic tumors are evaluated as metastatic lesions, not primary tumors of the pancreas.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- No intervention will be considered in this study.
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be considered in this study.Other
No intervention will be considered in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention will be considered in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: 5 years
Secondary outcomes (2)
DFS
disease free survival
Measured: 5 years
PFS
progress free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start31 Aug 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141656
- Sponsor's protocol ID
- CPOG-CDPC-01
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
- ClinicalTrials.gov ID
- NCT05141656
- Acronym / sponsor ID
- CPOG-CDPC-01
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: No intervention will be considered in this study.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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as tumor of pancreas will all be considered for enrollment.
Key inclusion criteria (5 listed)
- Age ≥ 18, both male and female;
- Patients with primary pancreatic tumor diagnosed by histology, cytology or imaging;
- Clinical or pathological staging is locally advanced or metastatic pancreatic tumor (newly diagnosed or after surgery and other treatments);
- You can accept or have not received surgery, chemotherapy, radiotherapy, local treatment or traditional Chinese medicine for tumors;
- The subject voluntarily joined the study and signed an informed consent form voluntarily.
Key exclusion criteria (1 listed)
- 1. Pancreatic tumors are evaluated as metastatic lesions, not primary tumors of the pancreas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be considered in this study.No intervention will be considered in this study. | Other | Single arm |
Primary outcome
OS
Time frame: 5 years
overall survival
2 secondary outcomes
DFS
Time frame: 5 years
PFS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.