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NCT04947995: MONITOR- GAC

Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

Status unknown Last updated 1 July 2021
What this trial tests

trial testing ctDNA multi-omics test in Gastric Cancer in 450 participants. Status unknown.

Timeline
15 June 2021
Primary endpoint
15 June 2023
15 June 2023

Quick facts

Lead sponsorGeneCast Biotechnology Co., Ltd.
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment450
Start date15 June 2021
Primary completion15 June 2023
Estimated completion15 June 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

GeneCast Biotechnology Co., Ltd.

Who can join

Adults 40 to 88, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel biomarkers for early detection of gastric cancer.
    Matsuoka T, Yashiro M. · · 2023 · cited 60× · PMID 37213407 · DOI 10.3748/wjg.v29.i17.2515
  2. Research progress of CTC, ctDNA, and EVs in cancer liquid biopsy.
    Wang X, Wang L, Lin H, Zhu Y, et al · · 2024 · cited 54× · PMID 38333685 · DOI 10.3389/fonc.2024.1303335
  3. The Role of ctDNA in Gastric Cancer.
    Mencel J, Slater S, Cartwright E, Starling N. · · 2022 · cited 26× · PMID 36291888 · DOI 10.3390/cancers14205105
  4. Clinical applications and perspectives of circulating tumor DNA in gastric cancer.
    Li JH, Zhang DY, Zhu JM, Dong L. · · 2024 · cited 14× · PMID 38184573 · DOI 10.1186/s12935-024-03209-4
  5. Translational Bioinformatics Applied to the Study of Complex Diseases.
    Casotti MC, Meira DD, Alves LNR, Bessa BGO, et al · · 2023 · cited 12× · PMID 36833346 · DOI 10.3390/genes14020419
  6. DNA methylation biomarkers for early detection of gastric and colorectal cancers.
    Gao X, Liu H, Yu J, Nie Y. · · 2024 · cited 5× · PMID 38318978 · DOI 10.20892/j.issn.2095-3941.2023.0443

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Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

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