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

NCT ID: NCT04636788

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreas Adenocarcinoma

Keywords

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exosome snoRNA endoscopic ultrasound liquid biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pancreatic cancer group

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

Group Type OTHER

Venous sampling

Intervention Type PROCEDURE

venous sampling of 12ml

Interventions

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Venous sampling

venous sampling of 12ml

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Bin Cheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Cheng, Professor

Role: CONTACT

Phone: 13986097542

Email: [email protected]

Facility Contacts

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Bin Cheng, Professor

Role: primary

Other Identifiers

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E-sR2020

Identifier Type: -

Identifier Source: org_study_id