Application Value of CTCs Detection for Advanced Gastric Cancer Patients

NCT ID: NCT03156777

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-12-31

Brief Summary

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Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.

Detailed Description

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Conditions

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Circulating Tumor Cells Gastric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Subjects eligible for enrollment must meet all of the following criteria:

1. Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
2. Men or women aged \>= 18 years and \<=75 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2.
4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
5. Metastatic disease or locally advanced disease not amenable to curative surgery.
6. Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
7. Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment.
8. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
9. No prior chemotherapy for advanced disease. -

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Gastric carcinoid, sarcomas, or squamous cell cancer.
2. Pregnant or lactating females.
3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
4. Active Hepatitis B or C or history of an HIV infection.
5. Active uncontrolled infection. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Lu, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Yinbing Liu, M.D. & Ph.D.

Role: STUDY_CHAIR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Zhou, M.D. & Ph.D.

Role: CONTACT

+862125078999

Beiqing Jiang

Role: CONTACT

+862125078922

Facility Contacts

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Beiqing Jiang

Role: primary

+862125078922

Other Identifiers

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XH-16-038

Identifier Type: -

Identifier Source: org_study_id

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