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Application of abnormal amplification detection of HER2 gene based on circulating tumor DNA in precise diagnosis and treatment of gastric cancer

Application of abnormal amplification detection of HER2 gene based on circulating tumor DNA in precise diagnosis and treatment of gastric cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018898
Enrollment
Unknown
Registered
2018-10-16
Start date
2018-05-22
Completion date
Unknown
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Gold Standard:The expression of HER2 was confirmed by immunohistochemistry and FISH in pathological specimens of gastric cancer patients.
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Sponsors

Shenzhen Nanshan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Seventy-five patients with gastric cancer admitted to Nanshan Hospital underwent open or laparoscopic surgery and were diagnosed as gastric cancer by histopathology. According to the TNM staging standard (2016, eighth edition) published by the International Anti-Cancer Alliance/United States Joint Cancer Committee (UICC/AJCC), the primary lesions were determined by size, depth of invasion, and lymph nodes. Stage I-IV staging was performed under the condition of degree of obstinate metastasis and distant metastasis. All patients did not receive any chemotherapy, radiotherapy or immunotherapy before operation. After informed consent, 37 healthy volunteers were selected as controls in the same period; (2) Thirty patients with TNM stage III and IV advanced gastric cancer (at least 30 cases) were selected to be included in the dynamic monitoring study. The abnormal amplification of HR2 gene in peripheral blood was detected before operation, one month after operation and every three months, and the clinical characteristics such as imaging and therapeutic reactivity were recorded in detail; (3) IHC and FISH were performed in all patients with gastric cancer. According to the "Guidelines for HER2 Detection of Gastric Cancer (2016 edition)", IHC was detected in the tissue samples first. IHC score of 3 + was judged to be HER2 positive, IHC score of 0 and 1 + was judged to be negative, and IHC score of 2 + was judged to be HER2 positive. The situation.

Exclusion criteria

Exclusion criteria: No

Design outcomes

Primary

MeasureTime frame
Detection of HER2 gene FISH in pathological specimens;Immunohistochemical detection of HER2 gene in pathological specimens;Her2 ctDNA Abnormal amplification;

Countries

China

Contacts

Public ContactJihui Du

Shenzhen Nanshan People's Hospital

jihuidu@email.szu.edu.cn+86 13510083963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026