ncRNAs in Exosomes of Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03102268
• Other study ID #: EXO-CN-1607
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2017
• Last updated: March 30, 2017
• Start date: May 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2017
• Source: The Second Hospital of Nanjing Medical University
• Contact: Lin Miao, MD
• Phone: 086-25-58509932
• Email: miaolinxh[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by many types of cells. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced.Exosomes contain proteins,RNAs and lipid,which may transfer biological information and activities from donor cells to receptor cells. Non-coding RNAs are involved in many biological activities including tumor growth and metastasis.

In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after surgical resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1.Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures.

2.Men or women aged >= 18 years. 3.Histology- or imaging-confirmed bile duct stricture. 4.Metastatic disease or locally advanced disease not amenable to curative surgery.

5.Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.

6.Life expectancy of at least 8 weeks from the time of enrollment. 7.No other malignancy within the past 5 years. 8.No prior chemotherapy for advanced disease.

Exclusion Criteria:

• 1.Pregnant or lactating females. 2.Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.

3.Active Hepatitis B or C or history of an HIV infection. 4.Active uncontrolled infection.

Related Conditions & MeSH terms

• Benign Biliary Stricture
• Cholangiocarcinoma

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the ncRNAs	Characterization of the ncRNAs in tumor derived exosomes from cholangiocarcinoma patients before anti-cancer therapies and benign biliary stricture patients	Up to 3 years from start of study
Secondary	Overall survival	Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until death) and time-to-event end-points	Up to 3 years from start of the study
Secondary	Progression-free survival	Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until tumor progression) and time-to-event end-points	Up to 3 years from start of the study