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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03434912
Other study ID # MiC-SRS-HNSCC-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 24, 2017
Est. completion date April 30, 2020

Study information

Verified date May 2018
Source MiCareo Taiwan Co., Ltd.
Contact Wang Shin-Hang
Phone 886-2796-5096
Email henrywang@micareo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 30, 2020
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
MiCareo Taiwan Co., Ltd. Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circulating tumor cell Isolation and analysis of circulating tumor cells before and after immunotherapy 1 years
Secondary tumor related rare cell Isolation and analysis of tumor related rare cells before and after immunotherapy 1 years