HER2 Positive CTC in Advanced Gastric Cancer (AGC-HER2CTC)
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|ClinicalTrials.gov Identifier: NCT01847794|
Recruitment Status : Unknown
Verified May 2013 by Shen Lin, Peking University.
Recruitment status was: Not yet recruiting
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|HER2 Positive Advanced Gastric Cancer||Device: Cell Search® CTC epithelial kit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2016|
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.
- HER2 positive CTC [ Time Frame: 2 months ]
- clinical significance of HER 2 positive CTC [ Time Frame: 2years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847794
|Contact: lin shen, MD. PhD||(86)firstname.lastname@example.org|
|Peking cancer hospital||Not yet recruiting|
|Beijing, Beijing, China, 100142|
|Contact: xiaotian zhang, MD. PhD (86)10-88196561 email@example.com|
|Contact: jifang gong, MD. PhD (86)10-88196561 firstname.lastname@example.org|
|Principal Investigator:||Lin Shen, MD. PhD||Peking University|