NCT05596435

Brief Summary

The purpose of this study is to enable non-invasive early detection of pancreatic cancer in high-risk populations through the establishment of a machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage pancreatic cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and the status of KRAS gene mutation, will be assessed to generate this model.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

October 10, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 24, 2022

Last Update Submit

October 24, 2022

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Area under curve of the model for detecting stage I/II/III pancreatic cancer

    The area under curve of the model for the ultrasensitive early detection of stage I/II/III pancreatic cancer would be evaluate

    2 years

Secondary Outcomes (2)

  • Sensitivity of the early detection modell

    2 years

  • Specificity of the early detection model

    2 years

Study Arms (3)

Stage I-III pancreatic cancer

Cell-free DNA collected from plasma samples of 260 patients with stage I-III pancreatic cancer will undergo whole-genome sequencing

Other: No intervention

Pancreatic disease

Cell-free DNA collected from plasma samples of 80 patients with pancreatic benign disease will undergo whole-genome sequencing

Other: No intervention

Healthy controls

Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls

Other: No intervention

Interventions

No interventionOTHER

No intervention

Healthy controlsPancreatic diseaseStage I-III pancreatic cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 260 stage I/II/III gastric cancer patients, 70 patients with pancreatic benign diseases and 150 non-cancer controls

You may qualify if:

  • Age minimum 18 years
  • Participants must have histologically and/or cytologically confirmed stage I/II/III pancreatic cancer
  • Full access to the patients' clinical and pathological records
  • Ability to understand and the willingness to sign a written informed consent document
  • Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening

You may not qualify if:

  • Participants must not be pregnant or breastfeeding
  • Participants must not have prior cancer histories or a second non-pancreatic malignancy
  • Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
  • Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
  • Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
  • Participants with clinically important abnormalities or conditions unsuitable for blood collection
  • Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements or influence patient signing the written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Cell-free DNA

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gao Chuntao

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Chuntao, MD

CONTACT

15822757365gaochuntao@tjmuch.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

October 10, 2022

Primary Completion

October 12, 2023

Study Completion

October 12, 2024

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)