Identification and Evaluation of Circulating Tumor Cells and Tumor Related Rare Cells in Immunotherapy

• Conditions: CTC and Tumor Related Rare Cell

• Registration Number: NCT03434912
• Lead Sponsor: MiCareo Taiwan Co., Ltd.

Brief Summary

The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-15
• Status Verified: 2018-05
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16
• Primary Completion: 2018-12-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Over 20 years of age.
3. Cancer patients on immune checkpoint inhibitors.

Exclusion Criteria

1. Subjects who have other cancer history
2. Pregnant females
3. Subjects with active, known or suspected autoimmune disease.
4. Known history of human immunodeficiency virus (HIV)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating tumor cell	1 years	Isolation and analysis of circulating tumor cells before and after immunotherapy

Secondary Outcome Measures

Name	Time	Method
tumor related rare cell	1 years	Isolation and analysis of tumor related rare cells before and after immunotherapy

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan