Biomarkers of Pancreatic Cancer and New Way to Detection

NCT04549064 | Unknown

• 1 other identifier: 81672921
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Pancreatic Cancer

  Diagnosis based on the concentration of serum biomarkers

  through study completion, an average of 1 year

Study Arms (2)

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

diagnosis of pancreatic cancer DIAGNOSTIC_TEST

Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

Healthy Control; Patients with pancreatic cancer

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• West China Hospital: collaborator
• Xi'an Jiaotong University: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from pancreatic cancer patients and healthy controls

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• han su xia, professor

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

wang qi, master

CONTACT

0086-15991439170; wangqill1024@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CN (1)