Biliary Tract CancerNCT05667350
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
An observational study of Biliary Tract Cancer, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
Trial summary
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Blood drawing
- How many people
- 492 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2022to 30 Jun 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be recruited from participating medical centers and assigned into two arms, including participants with new diagnosis of biliary tract cancer and benign biliary tract diseases.
Who may be able to join
- Age 40-75 years at the day of consenting to the study.
- Able to provide a written informed consent
- Pathologically confirmed biliary tract cancers.
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw.
- Age 40-75 years at the day of consenting to the study.
- Able to provide a written informed consent.
- Confirmed diagnosis of benign biliary tract diseases.
- No prior radical treatment of the benign diseases prior to study blood draw.
Who cannot join
- Pregnancy or lactating women.
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.
- Recipients of blood transfusion within 7 days prior to study blood draw.
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.
- With other known malignant tumors or multiple primary tumors.
- Pregnancy or lactating women.
Show all 11Show fewer
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.
- Recipients of blood transfusion within 7 days prior to study blood draw.
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.
- Confirmed diagnosis of malignancies or precancerous lesion.
- A history of malignant tumors.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Leibo Xu, MD/PhD
Yuzi Zhang, MD/PhD, +86-021-60293798, Z_Zhangyuzi@163.com
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Bin Li, MD/PhD, +86-021-65564166, libinjeff@126.com
Yuzi Zhang, MD/PhD, +86-021-60293798, Z_Zhangyuzi@163.com
About this study
Official title: Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.
- Conditions
- Biliary Tract Cancer
- Being tested
- Blood drawing
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingOther
Blood drawing before anti-cancer therapy
Blood drawingOther
Blood drawing before radical treatment
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer. Receives: Other: Blood drawing | |
| Benign disease arm | Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases. Receives: Other: Blood drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the combined model in detection of biliary tract cancers.
Measured: 24 months
Secondary outcomes (2)
The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.
Measured: 24 months
The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start28 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Responsible party
- Principal investigator, Xiaoqing Jiang, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Xiaoqing Jiang, MD/PhD, Principal investigator, Eastern Hepatobiliary Surgery HospitalBin Li, MD/PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667350
- Sponsor's protocol ID
- RSCD2021021
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT05667350
- Acronym / sponsor ID
- RSCD2021021
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Dec 2022 (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.
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | Other: Blood drawingBaseline blood samples will be collected from participants newly diagnosed with biliary tract cancer. |
| Benign disease arm | – | Other: Blood drawingBaseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from participating medical centers and assigned into two arms, including participants with new diagnosis of biliary tract cancer and benign biliary tract diseases.
Key inclusion criteria (8 listed)
- Age 40-75 years at the day of consenting to the study.
- Able to provide a written informed consent
- Pathologically confirmed biliary tract cancers.
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw.
- Age 40-75 years at the day of consenting to the study.
Key exclusion criteria (11 listed)
- Pregnancy or lactating women.
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.
- Recipients of blood transfusion within 7 days prior to study blood draw.
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.
- With other known malignant tumors or multiple primary tumors.
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 |
|---|---|---|
| Blood drawingBlood drawing before anti-cancer therapy | Other | Cancer arm |
| Blood drawingBlood drawing before radical treatment | Other | Benign disease arm |
Primary outcome
The sensitivity and specificity of the combined model in detection of biliary tract cancers.
Time frame: 24 months
2 secondary outcomes
The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.
Time frame: 24 months
The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
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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.
Xiaoqing Jiang, MD/PhD principal investigator
Eastern Hepatobiliary Surgery Hospital
Bin Li, MD/PhD principal investigator
Eastern Hepatobiliary Surgery Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by Eastern Hepatobiliary Surgery Hospital at 2 sites 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 8 inclusion and 11 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Bin Li, MD/PhD (+86-021-65564166, libinjeff@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the combined model in detection of biliary tract cancers. (time frame: 24 months). 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 Dec 2022.