Collection of Real-world Data in a Single InstituteNCT05700188
Outcome of GI Cancer in NCKUH
An observational study of Collection of Real-world Data in a Single Institute, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were reviewed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Collection of Real-world Data in a Single Institute
- How many people
- 730 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2013to 31 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were retrospectively reviewed.
Who may be able to join
- All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31
Who cannot join
- No treatment or refuse treatment
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Cheng-Kung University Hospital
Tainan
National Institute of Cancer Research
Tainan
About this study
Official title: Explore the Diagnosis and Treatment Outcome of Alimentary Tract Cancer in National Cheng Kung University Hospital
Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were reviewed.
Read the detailed description
We would like to explore the treatment strategy and clinical outcome of alimentary tract cancer in National Cheng Kung University Hospital. The result could help physician to further realize the real world practice of cancer treatment in Taiwan and might also help clinician to optimize the diagnosis and treatment strategy in alimentary tract cancer patients. Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resectable | Patients with resectable pancreatic cancer | |
| Borderline resectable | Patients with borderline resectable pancreatic cancer | |
| Locally advanced | Patients with locally advanced unresectable pancreatic cancer | |
| Metastatic | Patients with metastatic pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival of patient received study treatment
Measured: 10 years
Secondary outcomes (1)
Progression-free survival (PFS)
Progression-free survival of patient received study treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2013
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Collection of Real-world Data in a Single InstituteStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700188
- Sponsor's protocol ID
- A-ER-108-113
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Su YY, Chao YJ, Wang CJ, Liao TK, Su PJ, Huang CJ, Chiang NJ, Yu YT, Tsai HM, Chen LT, Shan YS. The experience of neoadjuvant chemotherapy versus upfront surgery in resectable pancreatic cancer: a cross sectional study. Int J Surg. 2023 Sep 1;109(9):2614-2623. doi: 10.1097/JS9.0000000000000495.
PubMed 37300888
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Diagnosis and Treatment Outcome of Alimentary Tract Cancer in National Cheng Kung University Hospital
- ClinicalTrials.gov ID
- NCT05700188
- Acronym / sponsor ID
- A-ER-108-113
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Jan 2023 (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.
Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were reviewed.
Detailed description
We would like to explore the treatment strategy and clinical outcome of alimentary tract cancer in National Cheng Kung University Hospital. The result could help physician to further realize the real world practice of cancer treatment in Taiwan and might also help clinician to optimize the diagnosis and treatment strategy in alimentary tract cancer patients. Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resectable | – | –Patients with resectable pancreatic cancer |
| Borderline resectable | – | –Patients with borderline resectable pancreatic cancer |
| Locally advanced | – | –Patients with locally advanced unresectable pancreatic cancer |
| Metastatic | – | –Patients with metastatic pancreatic cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were retrospectively reviewed.
Key inclusion criteria (1 listed)
- All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31
Key exclusion criteria (1 listed)
- No treatment or refuse treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: 10 years
Overall survival of patient received study treatment
1 secondary outcome
Progression-free survival (PFS)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37300888Su YY, Chao YJ, Wang CJ, Liao TK, Su PJ, Huang CJ, Chiang NJ, Yu YT, Tsai HM, Chen LT, Shan YS. The experience of neoadjuvant chemotherapy versus upfront surgery in resectable pancreatic cancer: a cross sectional study. Int J Surg. 2023 Sep 1;109(9):2614-2623. doi: 10.1097/JS9.0000000000000495.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Collection of Real-world Data in a Single Institute, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 1 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (OS) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700188, which also lists 1 linked publication.
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 26 Jan 2023.