CholangiocarcinomaNCT03102268
ncRNAs in Exosomes of Cholangiocarcinoma
An observational study of Cholangiocarcinoma and Benign Biliary Stricture, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Benign Biliary Stricture
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 Mar 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Lin Miao, MD, 086-25-58509932, miaolinxh@163.com
About this study
Official title: Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients
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.
- Conditions
- Cholangiocarcinoma, Benign Biliary Stricture
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cholangiocarcinoma patients | cholangiocarcinoma patients without any anti-cancer therapy | |
| benign biliary stricture patients | benign biliary stricture patients without any therapy targeting the stricture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the ncRNAs
Characterization of the ncRNAs in tumor derived exosomes from cholangiocarcinoma patients before anti-cancer therapies and benign biliary stricture patients
Measured: Up to 3 years from start of study
Secondary outcomes (2)
Overall survival
Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until death) and time-to-event end-points
Measured: Up to 3 years from start of the study
Progression-free survival
Correlation of exosomes-derived ncRNAs(at baseline and monthly during therapy until tumor progression) and time-to-event end-points
Measured: Up to 3 years from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Miao, MD, Principal investigator, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102268
- Sponsor's protocol ID
- EXO-CN-1607
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33257140
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients
- ClinicalTrials.gov ID
- NCT03102268
- Acronym / sponsor ID
- EXO-CN-1607
- Conditions
- Cholangiocarcinoma, Benign Biliary Stricture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholangiocarcinoma patients | – | –cholangiocarcinoma patients without any anti-cancer therapy |
| benign biliary stricture patients | – | –benign biliary stricture patients without any therapy targeting the stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Overall survival
Time frame: Up to 3 years from start of the study
Progression-free survival
Time frame: Up to 3 years from start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 33257140Ge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Miao, MD principal investigator
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Benign Biliary Stricture, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Miao, MD (086-25-58509932, miaolinxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the ncRNAs (time frame: Up to 3 years from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.