NCT03434912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

August 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

February 7, 2018

Last Update Submit

August 14, 2018

Conditions

CTC and Tumor Related Rare Cell

Outcome Measures

Primary Outcomes (1)

  • Circulating tumor cell

    Isolation and analysis of circulating tumor cells before and after immunotherapy

    1 years

Secondary Outcomes (1)

  • tumor related rare cell

    1 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80 cancer patients undergoing immunotherapy

You may qualify if:

  • 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.
  • Over 20 years of age.
  • Cancer patients on immune checkpoint inhibitors.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Wang Shin-Hang

CONTACT

886-2796-5096henrywang@micareo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 15, 2018

Study Start

May 24, 2017

Primary Completion

December 30, 2018

Study Completion

April 30, 2020

Last Updated

August 16, 2018

Record last verified: 2018-05

Locations

TW(1)