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.
Recruitment Information
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
Administrative Informations
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