Pancreatic CancerNCT06585072
Pancreatic Cancer and Diabetes Mellitus
An observational study of Pancreatic Cancer and Surgery, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are: 1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Surgery, Diabetes Mellitus
- What is being tested?
- All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pancreatic cancer after pancreatic surgery
Who may be able to join
- 1. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital.
- -
Who cannot join
- 1. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
tuo li, 13918507887, zoe_leeto@hotmail.com
About this study
Official title: Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer
The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:
- Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
- Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.
The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.
Read the detailed description
Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.
- Conditions
- Pancreatic Cancer, Surgery, Diabetes Mellitus
- Being tested
- All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.
- Keywords
- Pancreatic Cancer, Surgery, Diabetes Mellitus, Risk factor
- Medical subject headings
- Pancreatic Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.Diagnostic test
All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association.
Measured: From enrollment to five years after the end of the surgery
Secondary outcomes (2)
Overall Survival
Measured: From enrollment to five years after the end of the surgery
Disease-Free Survival
Measured: From enrollment to five years after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start3 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
- Investigators
- tuo Li, Prof., Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585072
- Sponsor's protocol ID
- NMU-3CDM-2B
- Status last verified
- Jun 2025
- First submitted
- 2 Sep 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06585072
- Acronym / sponsor ID
- NMU-3CDM-2B
- Conditions
- Pancreatic Cancer, Surgery, Diabetes Mellitus
- Keywords
- Pancreatic Cancer, Surgery, Diabetes Mellitus, Risk factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Sep 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.
The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:
- Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
- Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.
The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.
Detailed description
Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pancreatic cancer after pancreatic surgery
Key inclusion criteria (2 listed)
- 1. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital.
- -
Key exclusion criteria (2 listed)
- 1. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form.
- -
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 |
|---|---|---|
| All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data. | Diagnostic test | – |
Primary outcome
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
Time frame: From enrollment to five years after the end of the surgery
The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association.
2 secondary outcomes
Overall Survival
Time frame: From enrollment to five years after the end of the surgery
Disease-Free Survival
Time frame: From enrollment to five years after the end of the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- 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.
tuo Li, Prof. study director
Shanghai Changzheng Hospital
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 Cancer and Surgery, run by Shanghai Changzheng 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuo Li, Doctor (86-13918507887, dr.lituo@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus) (time frame: From enrollment to five years after the end of the surgery). 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 1 Jul 2025.