AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric (ASCEND-Gastric)

February 10, 2022 updated by: Shanghai Zhongshan Hospital

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

ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

498

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
        • 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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment.

Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.

Description

Inclusion Criteria for Cancer Arm Participants:

  • Age 40-75 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • No prior cancer treatment (local or systematic) with either of the following:

A. Pathologically confirmed 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.

Exclusion Criteria for Cancer Arm Participants:

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

Inclusion Criteria for Benign Disease Arm Participants:

  • Age 40-75 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • Able to provide sufficient and qualified blood samples for study tests.
  • Have either of the following:

A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.

B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

  • Insufficient qualified blood sample for study test.
  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 7 days prior to study blood draw.
  • Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer arm
Baseline blood samples will be collected from new diagnosis cancer participants.
Diagnostic test: Blood draw and blood-based biomarkers analyses
blood-based biomarkers analyses
Benign disease arm
Baseline blood samples will be collected from new diagnosis benign gastric disease participants.
Diagnostic test: Blood draw and blood-based biomarkers analyses
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 gastric cancer.
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The differences of sensitivity and specificity in gastric cancer participants at different clinical stages.
Time Frame: 30 months
30 months
Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers.
Time Frame: 30 months
30 months
Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively.
Time Frame: 30 months
30 months

Other Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of a blood miRNA-based model in detecting 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 Sun, MD, Zhongshan Hospital, Fudan University,China
  • Principal Investigator: Xuefei Wang, MD, Zhongshan Hospital, Fudan University,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)

January 18, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

September 22, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2020-390R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Cancer

Clinical Trials on Blood draw and blood-based biomarkers analyses

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe