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HER2 Positive CTC in Advanced Gastric Cancer

NCT01847794 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-05-07

No results posted yet for this study

Summary

To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.

Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.

Conditions

  • HER2 Positive Advanced Gastric Cancer

Interventions

DEVICE

Cell Search® CTC epithelial kit

Collect peripheral blood sample of 50 gastric cancer patients pre-chemotherapy and post two cycles of chemotherapy(response evaluation). Blood samples will be transferred to central lab to detect HER2 positive CTCs by Cellsearch epithelial kit. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, MD. PhD · Peking University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847794 on ClinicalTrials.gov