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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
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief 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.


Condition or disease Intervention/treatment Phase
HER2 Positive Advanced Gastric Cancer Device: Cell Search® CTC epithelial kit Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: chemotheropy 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.





Primary Outcome Measures :
  1. HER2 positive CTC [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. clinical significance of HER 2 positive CTC [ Time Frame: 2years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having signed informed consent
  • Age≥ 18 years old
  • HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
  • Histologically confirmed gastric adenocarcinoma
  • Unresectable recurrent or metastatic disease
  • Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  • Measurable disease according to the RECIST criteria
  • Karnofsky performance status ≥70
  • Life expectancy of ≥3 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  • Serum albumin level ≥3.0g/dL
  • Serum AKP < 2.5 times ULN
  • Serum creatinine <ULN, and CCr < 60ml/min
  • Bilirubin level < 1.5 ULN
  • WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

  • Previous systemic therapy for metastatic gastric cancer
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  • Allergic constitution or allergic history to protium biologic product or any investigating agents.
  • Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  • Pregnancy or lactation period
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Legal incapacity

Information from the National Library of Medicine

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


Contacts
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Contact: lin shen, MD. PhD (86)10-88196175 lin100@medmail.com.cn

Locations
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China, Beijing
Peking cancer hospital Not yet recruiting
Beijing, Beijing, China, 100142
Contact: xiaotian zhang, MD. PhD    (86)10-88196561    zhangxtxx@gmail.com   
Contact: jifang gong, MD. PhD    (86)10-88196561    gongjifang@gmail.com   
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Lin Shen, MD. PhD Peking University

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Responsible Party: Shen Lin, Director of GI oncology, Peking University
ClinicalTrials.gov Identifier: NCT01847794     History of Changes
Other Study ID Numbers: CGOG5002
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases