ClinicalTrials.gg
Status unknownNCT04549064Updated Aug 23, 2021

Biomarkers of Pancreatic Cancer and New Way to Detection

An observational study in Pancreatic Cancer, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-23.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
600
Ages
20 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Total collection of pancreatic cancer: healthy control about 300:300. The study population met the inclusion and exclusion criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Diagnostic Test: diagnosis of pancreatic cancer

  • Healthy Control

    healthy controls had no history of benign pancreatic diseases and other benign and malignant tumors.

    Diagnostic Test: diagnosis of pancreatic cancer

Interventions

  • Diagnostic testdiagnosis of pancreatic cancer

    Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

06

What researchers measure

Primary outcomes

  1. Diagnosis of Pancreatic Cancer

    Diagnosis based on the concentration of serum biomarkers

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xian Jiaotong University
    Xi’an, Shanxi 710061, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2020 (actual). Primary completion is estimated for Dec 2021, 15 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2020
First posted
Sep 16, 2020
StartActual
Sep 1, 2020
Primary completionEst.
Dec 1, 2021
CompletionEst.
Dec 30, 2021
Last update
Aug 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04549064
Collaborators
West China Hospital, Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Sep 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Aug 23, 2021

Study contacts

wang qi, master
Contact
wangqill1024@163.com
0086-15991439170
han su xia, professor
study chair · First Affiliated Hospital of Xian Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion