Detecting early liver, biliary tract, and pancreatic cancers
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)
This study is trying to see if a new way of testing blood samples can help find early-stage liver, biliary tract, and pancreatic cancers in people who have cancer, those with benign diseases, and healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1608 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06139042 on ClinicalTrials.gov |
What this trial studies
LIBRARY is a prospective, multi-center, observational study designed to identify early-stage liver, biliary tract, and pancreatic cancers. The study combines assays of cell-free DNA methylation, serum protein, and microRNA to enhance detection accuracy. Approximately 458 participants with confirmed cancers, 330 individuals with benign diseases, and 820 healthy participants will be enrolled to evaluate the effectiveness of these biomarkers. Blood samples will be collected for analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40-75 with pathologically confirmed liver, biliary tract, or pancreatic cancers who have not received prior anti-cancer therapy.
Not a fit: Patients who are pregnant, lactating, or have received recent anti-cancer therapy or blood transfusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of liver, biliary tract, and pancreatic cancers, improving treatment outcomes.
How similar studies have performed: Other studies utilizing cfDNA and biomarker assays have shown promise in early cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Criteria: Inclusion Criteria for Cancer Arm Participants: 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. Exclusion Criteria for Cancer Arm Participants: 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. Inclusion Criteria for Benign Arm Participants: 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. Exclusion Criteria for Benign Arm Participants: 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. Inclusion Criteria for Healthy Arm Participants: * 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. Exclusion Criteria for Healthy Arm Participants: * 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.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yuan Ding, Phd
- Email: dingyuan@zju.edu.cn
- Phone: +8657187783820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.