Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study

April 21, 2022 updated by: Shanghai Zhongshan Hospital
This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Peritoneal metastasis (PM) in gastric cancer is associated with a poor prognosis.

Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. However, the laparoscopy is invasive and the sensitivity of computed tomography (CT) scan is poor for detecting PM. Therefore, it is necessary to evaluate the feasibility of cfDNA methylation and other blood-based biomarkers for the PM diagnosis.

The study will enroll 384 participants with gastric cancer. Baseline blood and diagnosis of PM by laparoscopy with cytology will be collected. Participants with PM will be defined as the case arm and participants without PM will be defined as the control arm. A PM diagnostic model will be developed.

Study Type

Observational

Enrollment (Anticipated)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University, Shanghai, China
        • Principal Investigator:
          • Yihong Sun, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants of gastric cancer without any types of tumor treatment will be recruited.

Description

Inclusion Criteria:

  • Inclusion Criteria for Case Arm Participants:

    1. Age 18-74 years at the day of consenting to the study.
    2. Able to provide a written informed consent.

    3. No prior cancer treatment (local or systematic) with either of the following:

      A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.

      B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

    4. Diagnosis of peritoneal metastasis by laparoscopy with cytology.

  • Inclusion Criteria for Control Arm Participants:

    1. Age 18-74 years at the day of consenting to the study.
    2. Able to provide a written informed consent.

    3. No prior cancer treatment (local or systematic) with either of the following:

      A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.

      B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

    4. No peritoneal metastasis detected by laparoscopy with cytology.

Exclusion Criteria:

  • Exclusion Criteria for All Participants:

    1. Insufficient qualified blood samples.
    2. During pregnancy or lactation.
    3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
    4. Recipient of blood transfusion within 7 days prior to blood draw.
    5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
    6. With other known malignant tumors or multiple primary tumors.

  • Exclusion Criteria for Control Arm Participants:

    1. Insufficient qualified blood samples.
    2. During pregnancy or lactation.
    3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
    4. Recipient of blood transfusion within 7 days prior to blood draw.
    5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
    6. With other known malignant tumors or multiple primary tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case arm - Gastric cancer with peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants with peritoneal metastasis.
Other: Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses
Control arm - Gastric cancer without peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants without peritoneal metastasis.
Other: Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer.
Time Frame: 30 months
30 months
Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Guangzhou Burning Rock Bioengineering Ltd.

Investigators

  • Principal Investigator: Yihong Sun, Ph. D, Zhongshan Hospital, Fudan University, Shanghai, China
  • Principal Investigator: Xuefei Wang, Ph. D, Zhongshan Hospital, Fudan University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2030

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-081R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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