ncRNAs in Exosomes of Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT03102268|
Recruitment Status : Unknown
Verified March 2017 by The Second Hospital of Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
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|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
cholangiocarcinoma patients without any anti-cancer therapy
benign biliary stricture patients
benign biliary stricture patients without any therapy targeting the stricture
- 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
- 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
- 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
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
|Contact: Lin Miao, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Lin Miao, MD||Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|