Pancreatic CancerNCT04549064
Biomarkers of Pancreatic Cancer and New Way to Detection
An observational study of Pancreatic Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Amphoteric regulatory protein (AREG), a member of epidermal growth factor (EGF) family, is expressed in many tumors.Our study confirmed that the expression of AREG in the serum of patients with pancreatic cancer is significantly higher than that of patients with benign pancreatic diseases and healthy people, which is… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- diagnosis of pancreatic cancer
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Dec 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Total collection of pancreatic cancer: healthy control about 300：300. The study population met the inclusion and exclusion criteria.
Who may be able to join
- The healthy control group had no history of benign pancreatic diseases and other benign and malignant tumors.
- Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual.
Who cannot join
- Uncontrolled active infection.
- Acute or chronic pancreatitis.
- It is accompanied by other uncontrolled malignant tumors.
- Any other uncontrolled active disease that prevents participation in the trial.
- Having a history of mental illness that is difficult to control.
- In the opinion of the investigator, the presence of medical or psychiatric history or laboratory abnormalities may increase the risk associated with participation in the study or the administration of the study drug, or may interfere with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061
han su xia, professor, 0086-18991232029, shan87@mail.xjtu.edu.cn
About this study
Official title: Identification of AREG for the Detection of Pancreatic Cancer By Biosensor
Amphoteric regulatory protein (AREG), a member of epidermal growth factor (EGF) family, is expressed in many tumors.Our study confirmed that the expression of AREG in the serum of patients with pancreatic cancer is significantly higher than that of patients with benign pancreatic diseases and healthy people, which is expected to become a new early serum marker of pancreatic cancer. The serum concentration of AREG was detected by traditional ELISA and compared with CA-199, which was a conventional tumor marker of pancreatic cancer. Next, we compare the advantages of using sensor to detect AREG compared with ELISA.
Read the detailed description
Serum was collected ： pancreatic cancer : healthy control =200:200 Clinical data were collected: age, gender, diagnosis, cancer stage, CA199 level at initial diagnosis, histopathological type, etc. The informed consent of the subjects was obtained before the study, and all experimental procedures were approved by ethics.
Draw a summary table of patient characteristics. The level of AREG was detected by ELISA kit and compared with CA199.
Fabrication of a new electrochemical biosensor. Characterization of sensor performance.
- Conditions
- Pancreatic Cancer
- Being tested
- diagnosis of pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of pancreatic cancerDiagnostic test
Diagnosis of pancreatic cancer based on the concentration of serum biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic cancer | Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual. Receives: Diagnostic Test: diagnosis of pancreatic cancer | |
| Healthy Control | healthy controls had no history of benign pancreatic diseases and other benign and malignant tumors. Receives: Diagnostic Test: diagnosis of pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Pancreatic Cancer
Diagnosis based on the concentration of serum biomarkers
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (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 First Affiliated Hospital Xi'an Jiaotong 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- han su xia, professor, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549064
- Sponsor's protocol ID
- 81672921
- Status last verified
- Aug 2021
- First submitted
- 9 Sep 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of AREG for the Detection of Pancreatic Cancer By Biosensor
- ClinicalTrials.gov ID
- NCT04549064
- Acronym / sponsor ID
- 81672921
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, Xi'an Jiaotong University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 16 Sep 2020 (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.
Amphoteric regulatory protein (AREG), a member of epidermal growth factor (EGF) family, is expressed in many tumors.Our study confirmed that the expression of AREG in the serum of patients with pancreatic cancer is significantly higher than that of patients with benign pancreatic diseases and healthy people, which is expected to become a new early serum marker of pancreatic cancer. The serum concentration of AREG was detected by traditional ELISA and compared with CA-199, which was a conventional tumor marker of pancreatic cancer. Next, we compare the advantages of using sensor to detect AREG compared with ELISA.
Detailed description
Serum was collected ： pancreatic cancer : healthy control =200:200 Clinical data were collected: age, gender, diagnosis, cancer stage, CA199 level at initial diagnosis, histopathological type, etc. The informed consent of the subjects was obtained before the study, and all experimental procedures were approved by ethics.
Draw a summary table of patient characteristics. The level of AREG was detected by ELISA kit and compared with CA199.
Fabrication of a new electrochemical biosensor. Characterization of sensor performance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic cancer | – | Diagnostic Test: diagnosis of pancreatic cancerPatients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual. |
| Healthy Control | – | Diagnostic Test: diagnosis of pancreatic cancerhealthy controls had no history of benign pancreatic diseases and other benign and malignant tumors. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Total collection of pancreatic cancer: healthy control about 300：300. The study population met the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- The healthy control group had no history of benign pancreatic diseases and other benign and malignant tumors.
- Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual.
Key exclusion criteria (6 listed)
- Uncontrolled active infection.
- Acute or chronic pancreatitis.
- It is accompanied by other uncontrolled malignant tumors.
- Any other uncontrolled active disease that prevents participation in the trial.
- Having a history of mental illness that is difficult to control.
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 |
|---|---|---|
| diagnosis of pancreatic cancerDiagnosis of pancreatic cancer based on the concentration of serum biomarkers | Diagnostic test | Healthy Control, Patients with pancreatic cancer |
Primary outcome
Diagnosis of Pancreatic Cancer
Time frame: through study completion, an average of 1 year
Diagnosis based on the concentration of serum biomarkers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
han su xia, professor study chair
First Affiliated Hospital of Xian Jiaotong University
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, run by First Affiliated Hospital Xi'an Jiaotong 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 6 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang qi, master (0086-15991439170, wangqill1024@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Pancreatic Cancer (time frame: through study completion, an average of 1 year). 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 23 Aug 2021.