Pancreatic Ductal AdenocarcinomaNCT06344299
Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma
An observational study of Pancreatic Ductal Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- potential predictors
- How many people
- 5,302 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Sep 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 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Researchers included all elderly patients with T1-T3 stage PDAC recorded in SEER program, which would be candidates for undergoing radical surgery. Patients with metastatic disease were excluded. In addition, Investigators want to demonstrate survival benefit of radical surgery for elderly patients, so patients without complete survival time were excluded.
Who may be able to join
- patients older than 75 years old and were diagnosed with pancreatic ductal adenocarcinoma by positive histology.
- Patients were diagnosed with T1 through T3, M0 tumor based on criteria of TNM stage.
Who cannot join
- Patients were diagnosed by death certificate.
- Patients died before radical surgery.
- Patients with important data missing, such as T-stage, surgical resection status, surgery procedures and complete survival time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affliated to Fudan University
More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.
Read the detailed description
The incidence of pancreatic ductal adenocarcinoma (PDAC) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. Pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. Unfortunately, there are many a study had reported that the rate of radical surgery of patients with PDAC has been low in the past decade. In order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with PDAC from SEER program and investigated predictive factors associated with surgical resection abandonment. In this study, investigators extracted data of patients older than 75 years diagnosed with T1-T3 stage PDAC to investigate rate of radical surgery. And researchers used Univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- potential predictors
- Keywords
- pancreatic ductal adenocarcinoma, elderly, treatment abandonment, relative weight analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potential predictorsOther
Researchers want to investigate some important factors that influence elderly patients not to undergo radical surgery.
| Study group | Role | What they receive |
|---|---|---|
| group of undergoing radical surgery | Elderly patients diagnosed with resectable PDAC underwent radical surgery. | |
| group of abandoning radical surgery | Elderly patients diagnosed with resectable PDAC abandoned radical surgery, the reasons of treatment abandonment included surgeons didn't recommend surgery for their elderly patients and patients chose to refuse surgery. Receives: Other: potential predictors |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORs of potential predictors
Univariate and multivariate logistic regression model were used to calculate ORs
Measured: months from diagnosis to surgical resection, up to 12 months
Secondary outcomes (1)
Overall survival (OS)
The date of definite diagnosis to death or last follow up
Measured: up to 132 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 5,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344299
- Sponsor's protocol ID
- HuaDong Hosiptal of FUDAN
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affliated to Fudan University
- ClinicalTrials.gov ID
- NCT06344299
- Acronym / sponsor ID
- HuaDong Hosiptal of FUDAN
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreatic ductal adenocarcinoma, elderly, treatment abandonment, relative weight analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,302 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Apr 2024 (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.
More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.
Detailed description
The incidence of pancreatic ductal adenocarcinoma (PDAC) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. Pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. Unfortunately, there are many a study had reported that the rate of radical surgery of patients with PDAC has been low in the past decade. In order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with PDAC from SEER program and investigated predictive factors associated with surgical resection abandonment. In this study, investigators extracted data of patients older than 75 years diagnosed with T1-T3 stage PDAC to investigate rate of radical surgery. And researchers used Univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of undergoing radical surgery | – | –Elderly patients diagnosed with resectable PDAC underwent radical surgery. |
| group of abandoning radical surgery | – | Other: potential predictorsElderly patients diagnosed with resectable PDAC abandoned radical surgery, the reasons of treatment abandonment included surgeons didn't recommend surgery for their elderly patients and patients chose to refuse surgery. |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Researchers included all elderly patients with T1-T3 stage PDAC recorded in SEER program, which would be candidates for undergoing radical surgery. Patients with metastatic disease were excluded. In addition, Investigators want to demonstrate survival benefit of radical surgery for elderly patients, so patients without complete survival time were excluded.
Key inclusion criteria (2 listed)
- patients older than 75 years old and were diagnosed with pancreatic ductal adenocarcinoma by positive histology.
- Patients were diagnosed with T1 through T3, M0 tumor based on criteria of TNM stage.
Key exclusion criteria (3 listed)
- Patients were diagnosed by death certificate.
- Patients died before radical surgery.
- Patients with important data missing, such as T-stage, surgical resection status, surgery procedures and complete survival time.
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 |
|---|---|---|
| potential predictorsResearchers want to investigate some important factors that influence elderly patients not to undergo radical surgery. | Other | group of abandoning radical surgery |
Primary outcome
ORs of potential predictors
Time frame: months from diagnosis to surgical resection, up to 12 months
Univariate and multivariate logistic regression model were used to calculate ORs
1 secondary outcome
Overall survival (OS)
Time frame: up to 132 months
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 3 Apr 2024.
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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 Ductal Adenocarcinoma, run by Fudan University 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 2 inclusion and 3 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 3 Apr 2024. 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?
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?
ORs of potential predictors (time frame: months from diagnosis to surgical resection, up to 12 months). 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 3 Apr 2024.