ncRNAs in Exosomes of Cholangiocarcinoma

Brief Title

ncRNAs in Exosomes of Cholangiocarcinoma

Official Title

Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients

Brief 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.
    

Study Type

Observational [Patient Registry]

Primary Outcome

Characterization of the ncRNAs

Secondary Outcome

 Overall survival

Condition

Cholangiocarcinoma

Study Arms / Comparison Groups

 cholangiocarcinoma patients

Description:  cholangiocarcinoma patients without any anti-cancer therapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

80

Start Date

May 1, 2017

Completion Date

March 31, 2020

Primary Completion Date

March 31, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lin Miao, MD, 086-25-58509932, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03102268

Organization ID

EXO-CN-1607

Responsible Party

Sponsor

Study Sponsor

The Second Hospital of Nanjing Medical University

Study Sponsor

Lin Miao, MD, Principal Investigator, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Verification Date

March 2017