Pancreatic Ductal AdenocarcinomaNCT04726956
A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of PDAC
An observational study of Pancreatic Ductal Adenocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
The purpose of this study is to clarify the diagnostic significance of AKR1B10 in patients with pancreatic ductal adenocarcinoma, and to combine with CA19-9 to improve the diagnosis rate of pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- How many people
- 258 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2021to 1 Feb 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population included in the case group was patients with clinically and pathologically clear pancreatic ductal adenocarcinoma; and the population included in the benign group was patients with clinically and pathologically clear IPMN, mucinous cystadenoma, or pancreas cyst; and the population included in the control group was a healthy population without any benign or malignant diseases.
Who may be able to join
None listed.
Who cannot join
- 1. PDAC group:
- Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery;
- Patients with non-primary pancreatic cancer;
- Patients undergoing secondary operations;
- Infected with HIV or AIDS related diseases;
- Diagnosed as chronic or acute gastroenteritis;
Show all 13Show fewer
- Pregnant women;
- Other situations that are not suitable for this research; 2. Benign group
- Patients who have undergone related surgical treatment in other hospitals; (2) Patients with a history of malignant tumors; 3. Healthy group:
- Patients with a history of tumor;
- Tumors found in medical examinations;
- History of hepatitis B or C;
- A history of acute or chronic gastroenteritis, cholecystitis, and cholangitis.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Changhai Hospital of Shanghai
Shanghai
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of Pancreatic Ductal Adenocarcinoma：A Multicenter Study
The purpose of this study is to clarify the diagnostic significance of AKR1B10 in patients with pancreatic ductal adenocarcinoma, and to combine with CA19-9 to improve the diagnosis rate of pancreatic ductal adenocarcinoma.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreatic ductal adenocarcinoma, CA199, AKR1B10
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 |
|---|---|---|
| case cohort | Pancreatic ductal adenocarcinoma patients (140) | |
| control cohort | healthy donors (140) | |
| Benign cohort | patients with Intraductal papillary mucinous tumor of the pancreas (IPMN), mucinous cystadenoma, or pancreatic cyst (30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CA199 and AKR1B10 were detected in the sera of PDAC patients and Benign patients before surgery, as well as in the sera of healthy donors
Measured: 1 week
Secondary outcomes (1)
CA125, CEA, and AFP were detected in the sera of PDAC and Benign patients before surgery, as well as in the sera of healthy donors
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2021
- Study completion1 Feb 2022
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 Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 258 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726956
- Sponsor's protocol ID
- SHLTQC-3
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2021
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of Pancreatic Ductal Adenocarcinoma：A Multicenter Study
- ClinicalTrials.gov ID
- NCT04726956
- Acronym / sponsor ID
- SHLTQC-3
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreatic ductal adenocarcinoma, CA199, AKR1B10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 27 Jan 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.
The purpose of this study is to clarify the diagnostic significance of AKR1B10 in patients with pancreatic ductal adenocarcinoma, and to combine with CA19-9 to improve the diagnosis rate of pancreatic ductal adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case cohort | – | –Pancreatic ductal adenocarcinoma patients (140) |
| control cohort | – | –healthy donors (140) |
| Benign cohort | – | –patients with Intraductal papillary mucinous tumor of the pancreas (IPMN), mucinous cystadenoma, or pancreatic cyst (30) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population included in the case group was patients with clinically and pathologically clear pancreatic ductal adenocarcinoma; and the population included in the benign group was patients with clinically and pathologically clear IPMN, mucinous cystadenoma, or pancreas cyst; and the population included in the control group was a healthy population without any benign or malignant diseases.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery;
- Patients with non-primary pancreatic cancer;
- Patients undergoing secondary operations;
- Infected with HIV or AIDS related diseases;
- Diagnosed as chronic or acute gastroenteritis;
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
CA199 and AKR1B10 were detected in the sera of PDAC patients and Benign patients before surgery, as well as in the sera of healthy donors
Time frame: 1 week
1 secondary outcome
CA125, CEA, and AFP were detected in the sera of PDAC and Benign patients before surgery, as well as in the sera of healthy donors
Time frame: 1 week
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 16 Oct 2024.
- 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.
3 sites 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 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites 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 0 inclusion and 13 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
CA199 and AKR1B10 were detected in the sera of PDAC patients and Benign patients before surgery, as well as in the sera of healthy donors (time frame: 1 week). 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 16 Oct 2024.