Hepatobiliary MalignanciesASCEND-HepNCT04835675
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
An observational study of Hepatobiliary Malignancies, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hepatobiliary Malignancies
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 496 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 30 Jun 2022
- 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 medical centers and assigned into two arms, including participants with new diagnosis of hepatobiliary malignancies and benign diseases of the hepatobiliary system.
Who may be able to join
- 40-75 years old
- Ability to comply with study procedures
- Ability to provide a written informed consent
- Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Confirmed diagnosis of benign diseases of the hepatobiliary system
- 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 anti-microbial therapy within 14 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 cancer
- Current diagnosis of other malignancies or multiple primary tumors
Show all 11Show fewer
- Diagnosis of benign diseases by histopathological assessments
- Inability to characterize whether the lesion is malignant or benign
- Prior or ongoing treatment of cancer
- Current or history of malignancies or precancerous lesions
- No confirmed diagnosis or inability to characterize a benign disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection
This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.
- Conditions
- Hepatobiliary Malignancies
- Being tested
- Multi-cancer early detection test
- Keywords
- Hepatobiliary malignancies, Liquid biopsy, Cell-free DNA, Early detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-cancer early detection testDevice
Blood collection and multi-cancer early detection testing
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test | |
| Benign Diseases Arm | Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%
Measured: 16 months
Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers
Measured: 16 months
Secondary outcomes (4)
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages
Measured: 16 months
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers
Measured: 16 months
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system
Measured: 16 months
Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start12 Mar 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary MalignanciesStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou BR
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835675
- Sponsor's protocol ID
- ZJYY-2020006
- Acronym
- ASCEND-Hep
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection
- ClinicalTrials.gov ID
- NCT04835675
- Acronym / sponsor ID
- ASCEND-Hep / ZJYY-2020006
- Conditions
- Hepatobiliary Malignancies
- Keywords
- Hepatobiliary malignancies, Liquid biopsy, Cell-free DNA, Early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou BR
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Apr 2021 (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 is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Device: Multi-cancer early detection testParticipants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected |
| Benign Diseases Arm | – | Device: Multi-cancer early detection testParticipants with benign diseases of the hepatobiliary system, from whom blood samples will be collected |
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 medical centers and assigned into two arms, including participants with new diagnosis of hepatobiliary malignancies and benign diseases of the hepatobiliary system.
Key inclusion criteria (7 listed)
- 40-75 years old
- Ability to comply with study procedures
- Ability to provide a written informed consent
- Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
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 anti-microbial therapy within 14 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 cancer
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 |
|---|---|---|
| Multi-cancer early detection testBlood collection and multi-cancer early detection testing | Device | Benign Diseases Arm, Cancer Arm |
Primary outcome
Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%
Time frame: 16 months
Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers
Time frame: 16 months
4 secondary outcomes
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages
Time frame: 16 months
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers
Time frame: 16 months
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system
Time frame: 16 months
Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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.
Mingxin Pan principal investigator
Zhujiang Hospital
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 Hepatobiliary Malignancies, run by Zhujiang Hospital 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 7 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: finished, as of the sponsor's last update on 2 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98% (time frame: 16 months). The study lists 2 primary outcomes in all. 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 2 Mar 2023.