Circulating Extracellular Exosomal Small RNA as Potential... | NCT04636788

Studies
Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer

NCT04636788

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Nov 19, 2020Actual

Enrollment

102Estimated

Phase

Not Applicable

Conditions

Pancreas Adenocarcinoma

Interventions

Venous sampling

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

Nov 2020

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

Nov 1, 2020Actual

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Nov 1, 2022Estimated

First Submitted Date

Nov 4, 2020

First Submission Date that Met QC Criteria

Nov 14, 2020

First Posted Date

Nov 19, 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

Nov 14, 2020

Last Update Posted Date

Nov 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bin Cheng, Professor, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.

Detailed Description

CA19-9 is the FDA approved biomarker for the diagnosis of pancreatic cancer. However, the specificity of CA19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough.

Tumor cells secret abundant exosomes in the early stage. Circulating tumor cells are detected mainly in the advanced stage. Meanwhile, the role of non-coding RNA draws more and more attention in tumor area. Exosomes protect inside RNA from plasma RNase. Compared with long RNA, small RNA, including miRNA, snoRNA, tRNA, piRNA could exist more stably.

By means of next-generation sequencing, we look forward to finding new exosomal small RNA biomarkers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pancreatic cancer group	Other	pancreatic cancer, anticipated participants: 68 other pancreatic lesions including MCN, SCN, IPMN, SPN without malignant pathological finding chronic pancreatitis cholangiocarcinoma healthy control anticipated participants: 34	Procedure: Venous sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venous sampling	Procedure	venous sampling of 12ml	pancreatic cancer group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
senstivity	sensitivity of exo-sRNA	up to 8 weeks
specificity	specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
survival time	relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group	up to 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18
pancreatic cancer patients
pancreatic lesions other than PAAD
chronic pancreatitis
cholangiocarcinoma

Exclusion Criteria:

diagnosed with other pathological types of cancer
treated with chemo/radio/surgery previously

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bin Cheng, Professor	Contact	13986097542		b.cheng@tjh.tjmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, HUST	Recruiting	Wuhan	Hubei	430030	China