Biomarkers of Pancreatic Cancer and New Way to Detection | NCT04549064

Studies
Biomarkers of Pancreatic Cancer and New Way to Detection

NCT04549064

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Aug 23, 2021Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

diagnosis of pancreatic cancer

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Sep 9, 2020

First Submission Date that Met QC Criteria

Sep 14, 2020

First Posted Date

Sep 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2021

Last Update Posted Date

Aug 23, 2021Actual

Name	Class
West China Hospital	OTHER
Xi'an Jiaotong University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
diagnosis of pancreatic cancer	Diagnostic Test	Diagnosis of pancreatic cancer based on the concentration of serum biomarkers	Healthy Control Patients with pancreatic cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of Pancreatic Cancer	Diagnosis based on the concentration of serum biomarkers	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wang qi, master	Contact	0086-15991439170		wangqill1024@163.com

Overall Officials

Name	Affiliation	Role
han su xia, professor	First Affiliated Hospital of Xian Jiaotong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Xian Jiaotong University	Recruiting	Xi’an	Shanxi	710061	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

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Browse Branches

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