Liver CancerNCT06139042
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers
An observational study of Liver Cancer and Biliary Tract Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer, Biliary Tract Cancer, Pancreatic Cancer
- What is being tested?
- Blood drawing
- How many people
- 1,608 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study included participants diagnosed with liver, biliary tract, and pancreatic cancers or benign diseases as well as participants with no known presence of malignancies or benign 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 liver, biliary tract and pancreatic 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 liver, biliary tract and pancreatic diseases. No prior radical treatment of the benign diseases prior to study blood draw.
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No cancer related symptoms within 30 days prior to study screening.
- Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
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. 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.
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- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Recipient of anti-infectious therapy within 14 days prior to study blood draw.
- Have received or are undergoing curative cancer treatment within three years prior to study screening.
- With autoimmune or other diseases with severe comorbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Weilin Wang, M.D., +8657187783820, wam@zju.edu.cn
About this study
Official title: Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)
LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA.
Read the detailed description
LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. The study will enroll approximately 458 participants diagnosed with liver, biliary tract, and pancreatic cancers, 330 individuals with corresponding benign diseases and 820 healthy participants.
- Conditions
- Liver Cancer, Biliary Tract Cancer, Pancreatic Cancer
- Being tested
- Blood drawing
- Medical subject headings
- Liver Neoplasms, Biliary Tract Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingDiagnostic test
The participants had their blood drawn.
| Study group | Role | What they receive |
|---|---|---|
| liver, biliary tract, and pancreatic cancers | participants with liver, biliary tract, and pancreatic cancers Receives: Diagnostic Test: Blood drawing | |
| liver, biliary tract, and pancreatic benign diseases | participants with liver, biliary tract, and pancreatic benign diseases Receives: Diagnostic Test: Blood drawing | |
| non-liver, biliary tract, and pancreatic diseases | Participants with no known presence of malignancies or benign diseases Receives: Diagnostic Test: 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 cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.
Measured: 24 months
Secondary outcomes (2)
The sensitivity and specificity of the combined model in detection of different subtypes of cancers.
Measured: 24 months
The sensitivity and specificity of the combined model in detection of different stages of liver, biliary tract and pancreatic 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 posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- 1,608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, Phd, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139042
- Sponsor's protocol ID
- 2023-0871
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No