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

August 14, 2018 updated by: MiCareo Taiwan Co., Ltd.

Identification and Evaluation of the Potential Biomarkers on Circulating Tumor Cells and Tumor Related Rare Cells in Cancer Patients Undergoing Immunotherapy

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

80 cancer patients undergoing immunotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor cell
Time Frame: 1 years
Isolation and analysis of circulating tumor cells before and after immunotherapy
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor related rare cell
Time Frame: 1 years
Isolation and analysis of tumor related rare cells before and after immunotherapy
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiCareo Taiwan Co., Ltd.

Collaborators

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiC-SRS-HNSCC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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