Identification and Evaluation of Circulating Tumor Cells... | NCT03434912

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

NCT03434912

Sponsor

MiCareo Taiwan Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 16, 2018Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

CTC and Tumor Related Rare Cell

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2017Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Feb 7, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2018

Last Update Posted Date

Aug 16, 2018Actual

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

80 cancer patients undergoing immunotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang Shin-Hang	Contact	886-2796-5096	621	henrywang@micareo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital	Recruiting	Taipei		11217	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided