Clinical Trials Directory

Trials / Unknown

UnknownNCT04520295

ctDNA Screening in Advanced HER2 Positive Gastric Cancer

Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Ruijin Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.

Detailed description

Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Conditions

Interventions

TypeNameDescription
GENETICctDNA screeningMolecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Timeline

Start date
2020-05-19
Primary completion
2023-05-31
Completion
2025-05-31
First posted
2020-08-20
Last updated
2020-08-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04520295. Inclusion in this directory is not an endorsement.