Pancreas CancerNCT03659903
Pancreaticoduodenectomy in Elderly Pancreatic Ductal Adenocarcinoma Patients
An observational study of Pancreas Cancer, run by The First Affiliated Hospital of Dalian Medical University.
Trial summary
We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 5,910 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 1 Sep 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Pancreatic ductal adenocarcinoma patients in the SEER database form 2003 to 2013.
Who may be able to join
- Patients with pancreatic ductal adenocarcinoma，treatment by pancreaticoduodenectomy.Only cases that underwent PD and microscopically confirmed were included.
Who cannot join
- Patients with no survival data.
About this study
Official title: Long-term Benefit of Elderly Pancreatic Ductal Adenocarcinoma Patients After Pancreaticoduodenectomy
We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status.
The aim of Our study is to make clearly the long-term survival of younger (age <80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent PD. Sec-ond, find out the risk factors of poor prognosis in elderly patients.
Read the detailed description
Database We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013, encompassing approxi-mately 28% of the USA population. All the malignant cases were followed-up annu-ally to determine vital status.
Patient Population All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included.
Outcome Variables We only included those PDAC patients that underwent PD with precise data available for the following variables: age at diagnosis, year of diagnosis, gender, race, tumor site, tumor size, regional nodes positive, regional nodes examined, grade, stage, vital status, and survival months.
To clearly differentiate the difference of long-term survival between young and elderly patients, all cases were divided into two group age < 80 years and age ≥ 80 years. Since 2004, the AJCC 6th stage has been used in the SEER database. Thus, the diagnosis years of the cases included in our study ranged from 2004-2013. To analyze the median OS between different time periods, we divided the year of diagnosis into two groups: 2004-2008 year and 2009-2013. Furthermore, we also divided the tumor size into three groups: ≤ 2 cm, 2-4 cm, and > 4 cm. The lymph node ratio (LNR) is considered a robust prognostic factor after resection of pancreatic cancer and was es-timated using regional nodes positive divided by regional nodes examined.15 LNR was then categorized into three groups: 0%, 1-50%, > 50%.
- Conditions
- Pancreas Cancer
- Being tested
- pancreaticoduodenectomy
- Keywords
- pancreatic ductal adenocarcinoma, pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| younger patients (age < 80) | age < 80 patients， All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included. Receives: Procedure: pancreaticoduodenectomy | |
| older patients (age≥ 80 ) | age ≥ 80 years-old patients，All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included. Receives: Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
median OS
The median overall survival of all patients
Measured: to 2013 Dec. 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jan 2004
- Primary completion13 Dec 2013
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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
- 5,910 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659903
- Sponsor's protocol ID
- YJ-KY-FB-2017-06
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Benefit of Elderly Pancreatic Ductal Adenocarcinoma Patients After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03659903
- Acronym / sponsor ID
- YJ-KY-FB-2017-06
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic ductal adenocarcinoma, pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,910 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 13 Dec 2013 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 6 Sep 2018 (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.
We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status.
The aim of Our study is to make clearly the long-term survival of younger (age <80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent PD. Sec-ond, find out the risk factors of poor prognosis in elderly patients.
Detailed description
Database We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013, encompassing approxi-mately 28% of the USA population. All the malignant cases were followed-up annu-ally to determine vital status.
Patient Population All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included.
Outcome Variables We only included those PDAC patients that underwent PD with precise data available for the following variables: age at diagnosis, year of diagnosis, gender, race, tumor site, tumor size, regional nodes positive, regional nodes examined, grade, stage, vital status, and survival months.
To clearly differentiate the difference of long-term survival between young and elderly patients, all cases were divided into two group age < 80 years and age ≥ 80 years. Since 2004, the AJCC 6th stage has been used in the SEER database. Thus, the diagnosis years of the cases included in our study ranged from 2004-2013. To analyze the median OS between different time periods, we divided the year of diagnosis into two groups: 2004-2008 year and 2009-2013. Furthermore, we also divided the tumor size into three groups: ≤ 2 cm, 2-4 cm, and > 4 cm. The lymph node ratio (LNR) is considered a robust prognostic factor after resection of pancreatic cancer and was es-timated using regional nodes positive divided by regional nodes examined.15 LNR was then categorized into three groups: 0%, 1-50%, > 50%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| younger patients (age < 80) | – | Procedure: pancreaticoduodenectomyage < 80 patients， All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included. |
| older patients (age≥ 80 ) | – | Procedure: pancreaticoduodenectomyage ≥ 80 years-old patients，All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pancreatic ductal adenocarcinoma patients in the SEER database form 2003 to 2013.
Key inclusion criteria (1 listed)
- Patients with pancreatic ductal adenocarcinoma，treatment by pancreaticoduodenectomy.Only cases that underwent PD and microscopically confirmed were included.
Key exclusion criteria (1 listed)
- Patients with no survival data.
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 |
|---|---|---|
| pancreaticoduodenectomypancreaticoduodenectomy | Procedure or surgery | older patients (age≥ 80 ), younger patients (age < 80) |
Primary outcome
median OS
Time frame: to 2013 Dec. 31
The median overall survival of all patients
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 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by The First Affiliated Hospital of Dalian Medical University.
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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
median OS (time frame: to 2013 Dec. 31). 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 6 Sep 2018.