This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in BileNCT05783973
Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas
An observational study of This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in matched tissue, blood , and bile samples of patients with Resectable Biliary Tract Carcinomas（BTC）. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
- What is being tested?
- Next generation sequencing
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2023to 2 Feb 2024
- 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: Planning to enroll 20 resectable BTC patients, age over 18 years old following the eligibility criteria.
Who may be able to join
- Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology
- Patients who signed informed consent form;
- Patients who agree and have the ability to follow the planned research visits, provide surgical tissue, blood, and bile samples, provide clinical information, and cooperate with other research steps.
Who cannot join
- a.Patients who be deemed unsuitable for enrollment by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510289
Songyao Liu, MD, 13754858677, liusy229@mail.sysu.edu.cn
About this study
Official title: A Single-Center Exploratory Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas by Using Burning Rock Gene Testing Platform
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in matched tissue, blood , and bile samples of patients with Resectable Biliary Tract Carcinomas（BTC）. In order to explore thefeasibility in bile cfDNA of BTC，we will collect relevant clinical information and follow-up treatment information. This study aims to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
Read the detailed description
In this study, we will investigate the potential of bile for genomic alterations using matched tissue, plasma and bile from 20 Resectable BTC Patients。The patient samples will be submitted for next-generation sequencing (NGS)，The results will include but will not be limited to genomic profling, tumor mutation burden (TMB), microsatellite instability (MSI) status, homologous recombination repair deficiency (HRD)。Patients will be followed-up for treatment responses until radiological confirmation of disease recurrence ,The molecular assay results will then be analyzed with clinical data including objective responses disease-free survival outcomes, among others, to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
Baseline tissues, plasma and sputum samples from 20 Resectable BTC Patients with 520 Panel sequencing (tissue 1000X, ,plasma cfDNA 10000X，bile 10000X), in different methods will be compared.
- Being tested
- Next generation sequencing
- Keywords
- resectable BTC，tissue, blood , and bile samples，genomic alterations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation sequencingDiagnostic test
Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.
| Study group | Role | What they receive |
|---|---|---|
| bile group | bile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X) Receives: Diagnostic Test: Next generation sequencing | |
| Tissue group | tissue samples from 20 resectable BTC patients with 520 Panel sequencing (tissue1000X) Receives: Diagnostic Test: Next generation sequencing | |
| Plasma group | plasma samples from 20 resectable BTC patients with 520 Panel sequencing (plasma 10000X) Receives: Diagnostic Test: Next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare different sample types with concordence rate, sensitivity, and specificity.
Concordance rate was defined as the fraction of the total number of true positive and true negative patients relative to the cohort or indicated subgroup; Sensitivity rate means true positive rate, true positive patients were defined as those who carried at least one genomic alteration that were detected in both matched samples.
Specificity rate means ture negative rate, patients were as defined true negative if no alteration was detected from either matched sample.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start2 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion2 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in BileStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changzhen Shang, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783973
- Sponsor's protocol ID
- SYSKY-2023-043-02
- Status last verified
- Feb 2023
- First submitted
- 13 Mar 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Exploratory Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas by Using Burning Rock Gene Testing Platform
- ClinicalTrials.gov ID
- NCT05783973
- Acronym / sponsor ID
- SYSKY-2023-043-02
- Keywords
- resectable BTC，tissue, blood , and bile samples，genomic alterations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 2 Feb 2024 (estimated)
- First posted
- 24 Mar 2023 (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.
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in matched tissue, blood , and bile samples of patients with Resectable Biliary Tract Carcinomas（BTC）. In order to explore thefeasibility in bile cfDNA of BTC，we will collect relevant clinical information and follow-up treatment information. This study aims to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
Detailed description
In this study, we will investigate the potential of bile for genomic alterations using matched tissue, plasma and bile from 20 Resectable BTC Patients。The patient samples will be submitted for next-generation sequencing (NGS)，The results will include but will not be limited to genomic profling, tumor mutation burden (TMB), microsatellite instability (MSI) status, homologous recombination repair deficiency (HRD)。Patients will be followed-up for treatment responses until radiological confirmation of disease recurrence ,The molecular assay results will then be analyzed with clinical data including objective responses disease-free survival outcomes, among others, to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
Baseline tissues, plasma and sputum samples from 20 Resectable BTC Patients with 520 Panel sequencing (tissue 1000X, ,plasma cfDNA 10000X，bile 10000X), in different methods will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bile group | – | Diagnostic Test: Next generation sequencingbile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X) |
| Tissue group | – | Diagnostic Test: Next generation sequencingtissue samples from 20 resectable BTC patients with 520 Panel sequencing (tissue1000X) |
| Plasma group | – | Diagnostic Test: Next generation sequencingplasma samples from 20 resectable BTC patients with 520 Panel sequencing (plasma 10000X) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Planning to enroll 20 resectable BTC patients, age over 18 years old following the eligibility criteria.
Key inclusion criteria (3 listed)
- Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology
- Patients who signed informed consent form;
- Patients who agree and have the ability to follow the planned research visits, provide surgical tissue, blood, and bile samples, provide clinical information, and cooperate with other research steps.
Key exclusion criteria (1 listed)
- a.Patients who be deemed unsuitable for enrollment by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next generation sequencingExtract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng. | Diagnostic test | Plasma group, Tissue group, bile group |
Primary outcome
Compare different sample types with concordence rate, sensitivity, and specificity.
Time frame: 1 years
Concordance rate was defined as the fraction of the total number of true positive and true negative patients relative to the cohort or indicated subgroup; Sensitivity rate means true positive rate, true positive patients were defined as those who carried at least one genomic alteration that were detected in both matched samples. Specificity rate means ture negative rate, patients were as defined true negative if no alteration was detected from either matched sample.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided
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.
Changzhen Shang, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 3 inclusion and 1 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 30 May 2023. 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 Changzhen Shang, MD (13711279678, shangchangzhen@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare different sample types with concordence rate, sensitivity, and specificity. (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.