Actively Recruiting

Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT05556603

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)

Led by Ruijin Hospital · Updated on 2023-05-06

7062

Participants Needed

3

Research Sites

365 weeks

Total Duration

On this page

Sponsors

R

Ruijin Hospital

Lead Sponsor

G

Guangzhou Burning Rock Dx Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.

CONDITIONS

Official Title

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 to 75 years old
  • Able to provide written informed consent
  • For cancer arm: Pathologically confirmed cancer diagnosis within 42 days before blood draw or high suspicion by imaging with confirmation within 42 days after blood draw
  • For benign disease arm: Pathological confirmation of benign disease within 90 days before blood draw without prior treatment or high suspicion with confirmation within 42 days after blood draw
  • For healthy arm: No cancer symptoms or abnormal medical exams within 30 days before screening; cancer history with curative treatment completed over 3 years ago without recurrence
  • For high risk arm: Known pancreatic cancer risk factors including pathogenic variants or chronic pancreatitis
  • Able to provide sufficient and qualified blood samples for study tests
Not Eligible

You will not qualify if you...

  • Insufficient qualified blood samples
  • Currently pregnant or lactating
  • Recipient of organ transplant or prior non-autologous bone marrow or stem cell transplant
  • Blood transfusion within 7 days prior to blood draw
  • Receipt of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw
  • Presence of other known malignant tumors or multiple primary tumors in cancer arm
  • Received radical therapy within 3 years without recurrence for malignant tumors with pathogenic or suspected pathogenic germ-line variants in high risk arm
  • Autoimmune or severe comorbid diseases in healthy arm

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

2

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Active, Not Recruiting

3

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Active, Not Recruiting

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Research Team

Q

Qian Zhan, M.D.

CONTACT

Y

Yuzi Zhang, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC) | DecenTrialz