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

Pancreas Adenocarcinoma Clinical Trial

Official title:

Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636788
• Other study ID #: E-sR2020
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2020
• Source: Huazhong University of Science and Technology
• Contact: Bin Cheng, Professor
• Phone: 13986097542
• Email: b.cheng[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Adenocarcinoma

Intervention

Procedure:
• Venous sampling
venous sampling of 12ml

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	senstivity	sensitivity of exo-sRNA	up to 8 weeks
Primary	specificity	specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions	up to 8 weeks
Secondary	survival time	relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group	up to 18 months