NCT05513144

Brief Summary

This study aims to evaluate the use of next generation sequencing (NGS) to detect circulating tumor DNA in advanced HER2 negative gastric cancer patients. The evaluation of the therapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. In this study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

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

December 24, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

August 21, 2022

Last Update Submit

February 2, 2023

Conditions

Gastric CancerCirculating Tumor DNA (ctDNA)

Keywords

Gastric CancerCirculating Tumor DNAPrognosisTherapy Response

Outcome Measures

Primary Outcomes (2)

  • Prognostic molecular markers.

    Change from baseline in molecular biomarkers at time on disease progression

    2 years

  • The sensitivity and specificity of ctDNA detection. Profiling of the most frequently detected gene mutations and level of mutations in ctDNA

    2 years

Secondary Outcomes (4)

  • Mutation profile and the concordance of mutations in tumor tissue and ctDNA of gastric cancer

    2 years

  • Mechanisms of therapy resistance

    2 years

  • The concordance and accuracy of response evaluation results determined by ctDNA compared with imaging and serum tumor biomarkers (CEA, CA19-9,CA72-4 et al).

    2 years

  • Relative frequency of targetable mutations (incl. TMB and MSI status).

    2 years

Eligibility Criteria

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

HER2 negative gastric cancer patients

You may qualify if:

  • Male or female patients age 18 - 75.
  • Histologically confirmed adenocarcinoma of gastric or gastro-oesophageal junction. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
  • HER2 status is confirmed by IHC/FISH. HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
  • At least one measurable lesion should be confirmed by imaging examination.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • No concomitant other malignant tumor or treated malignant tumor within last five years.
  • Eligible peripheral blood and tissue samples.
  • Willing to provide clinicopathological information and imaging information.

You may not qualify if:

  • Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
  • With second primary malignant diseases.
  • HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive.
  • No qualified paired tissue samples.
  • No complete clinicopathological information and follow-up.
  • Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
  • Other situations assessed by investigator can disturb quality control of the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor DNA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

chen wu

CONTACT

+86-519-68871192chenwucz@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Oncology

Study Record Dates

First Submitted

August 21, 2022

First Posted

August 24, 2022

Study Start

December 24, 2021

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CN(1)