NCT05269056

Brief Summary

The purpose of this study is to enable non-invasive early detection of gastric cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage gastric cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and microbiome, 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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

September 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

February 28, 2022

Last Update Submit

May 30, 2022

Conditions

Early Gastric Cancer

Keywords

Gastric cancerEarly stagePlasma Cell-free DNAFragmentomic assay

Outcome Measures

Primary Outcomes (1)

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

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

    2 years

Secondary Outcomes (3)

  • Sensitivity of the early detection model

    2 years

  • Specificity of the early detection model

    2 years

  • Area under curve of the early detection model at sequencing depth downsampling

    2 years

Study Arms (2)

Stage I-II gastric cancer

Cell-free DNA collected from plasma samples of 200 patients with stage I-II gastric cancer will undergo whole-genome sequencing

Healthy controls

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

Eligibility Criteria

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

Approximately 200 stage I/II gastric cancer patients and 100 non-cancer controls

You may qualify if:

  • Age minimum 18 years
  • Participants must have histologically and/or cytologically confirmed stage I/II gastric 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-gastric 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)

Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

  • Yu P, Chen P, Wu M, Ding G, Bao H, Du Y, Xu Z, Yang L, Fang J, Huang X, Lai Q, Wei J, Yan J, Yang S, He P, Wu X, Shao Y, Su D, Cheng X. Multi-dimensional cell-free DNA-based liquid biopsy for sensitive early detection of gastric cancer. Genome Med. 2024 Jun 7;16(1):79. doi: 10.1186/s13073-024-01352-1.

    PMID: 38849905DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Cell-free DNA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xiangdong Cheng, MD, PhD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yu, MD, PhD

CONTACT

86-571-88128031ypfzmu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 7, 2022

Study Start

September 1, 2021

Primary Completion

November 1, 2022

Study Completion

May 31, 2023

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)