NCT06166147

Brief Summary

This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2023Mar 2027

First Submitted

Initial submission to the registry

November 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

December 18, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

November 7, 2023

Last Update Submit

September 15, 2024

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer

    Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.

    12 months

Secondary Outcomes (2)

  • Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer

    12 months

  • Performance of pre-defined model in clinical sub-groups of interest

    12 months

Study Arms (2)

Cancer arm

Participants with new diagnosis of pancreatic cancer, from whom a peripheral blood sample will be collected.

Benign disease arm

Participants with benign pancreatic diseases, from whom a peripheral blood sample will be collected.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed pancreatic cancer or pancreatic non-malignant disease

You may qualify if:

  • years old
  • Clinically and/or pathologically diagnosed pancreatic cancer
  • No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
  • Able to provide a written informed consent and willing to comply with all part of the protocol procedures.

You may not qualify if:

  • Pregnancy or lactating women
  • Known prior or current diagnosis of other types of malignancies comorbidities
  • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 30 days prior to study blood draw
  • Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
  • Other conditions that the investigators considered are not suitable for the enrollment
  • Benign Disease Arm
  • years old
  • Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis)
  • No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
  • Able to provide a written informed consent and willing to comply with all part of the protocol procedures
  • Pregnancy or lactating women
  • Known prior or current diagnosis of other types of malignancies comorbidities
  • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Department of General Sugery, Huadong Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Xian-Jun Yu, M.D., Ph.D.

    Fudan University

    STUDY CHAIR

Central Study Contacts

Xian-Jun Yu, M.D., Ph.D.

CONTACT

+86 21 64175590yuxianjun@fudanpci.org

Si Shi, M.D., Ph.D.

CONTACT

+86 21 64175590

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2023

First Posted

December 12, 2023

Study Start

December 18, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)