Clinical trial NCT03102268: ncRNAs in Exosomes of Cholangiocarcinoma
Official title: Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Benign Biliary Stricture
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be adults with cholangiocarcinoma and benign biliary stricture, candidates to receive a first-line systemic therapy, who meet all of the inclusion criteria and none of the exclusion criteria within 28 days prior to the first day of study treatment.

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.


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.

Primary outcomes:
measure: Characterization of the ncRNAs
timeFrame: Up to 3 years from start of study
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 3 years from start of the study
measure: Progression-free survival
timeFrame: Up to 3 years from start of the study
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
name: Lin Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ge X, Tang L, Wang Y, Wang N, Zhou J, Deng X, Zhong Y, Li Q, Wang F, Jiang G, Miao L. The diagnostic value of exosomal miRNAs in human bile of malignant biliary obstructions. Dig Liver Dis. 2021 Jun;53(6):760-765. doi: 10.1016/j.dld.2020.11.010. Epub 2020 Nov 27.