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ncRNAs in Exosomes of Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT03102268
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

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.


Condition or disease
Cholangiocarcinoma Benign Biliary Stricture

Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients
Anticipated Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
cholangiocarcinoma patients
cholangiocarcinoma patients without any anti-cancer therapy
benign biliary stricture patients
benign biliary stricture patients without any therapy targeting the stricture



Primary Outcome Measures :
  1. Characterization of the ncRNAs [ Time Frame: Up to 3 years from start of study ]
    Characterization of the ncRNAs in tumor derived exosomes from cholangiocarcinoma patients before anti-cancer therapies and benign biliary stricture patients


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 3 years from start of the study ]
    Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until death) and time-to-event end-points

  2. Progression-free survival [ Time Frame: Up to 3 years from start of the study ]
    Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until tumor progression) and time-to-event end-points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102268


Contacts
Contact: Lin Miao, MD 086-25-58509932 miaolinxh@163.com

Locations
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Lin Miao, MD    086-25-58509932    miaolinxh@163.com   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
Principal Investigator: Lin Miao, MD Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03102268     History of Changes
Other Study ID Numbers: EXO-CN-1607
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms