Lymphocytes Subpopulation in Cancer Patients | NCT02516371

Studies
Lymphocytes Subpopulation in Cancer Patients

NCT02516371

Sponsor

DERSHENG SUN

Status

Unknown status

Last Update Posted

Aug 26, 2015Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

lymphocyte

Countries

South Korea

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

Aug 2015

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

Aug 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Aug 1, 2015

First Submission Date that Met QC Criteria

Aug 3, 2015

First Posted Date

Aug 5, 2015Estimated

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 25, 2015

Last Update Posted Date

Aug 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic correlations.

Detailed Description

The host's inflammatory response in the tumor microenvironment could effect cancer progression and prognosis. As components of systemic inflammatory response, lymphocytes, neutrophils, and platelets are being recognised to have an important role in carcinogenesis and tumor progression. To date, a number of peripheral blood-derived inflammation-based scores such as the neutrophil-lymphocyte ratio (NLR), platelet- lymphocyte ratio (PLR) and so on have been proposed as prognostic markers in numerous types of cancers. But, very little is known of their impact in subpopulation of lymphocytes. The investigators try to evaluate the activity of lymphocytes in peripheral blood and find out the relationship among clinical prognosis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lymphocytes	Other	To evaluate the subpopulation of lymphocytes in cancer patients	Other: lymphocyte

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lymphocyte	Other	To evaluate the subpopulation of lymphocytes in cancer patients	lymphocytes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate after cancer treatment with chemotherapy		6 months after chemotherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cancer patients of Uijeongbu St. Mary's Hospital
never treated with chemotherapy
Age between 20~80 years-

Exclusion Criteria:

treated with chemotherapy before
No informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoon Ho Ko, MD, PhD	Contact	82-31-820-3985		koyoonho@catholic.ac.kr
Der Sheng Sun, MD, PhD	Contact	82-31-820-3584		ds-sun@hanmail.net

Overall Officials

Name	Affiliation	Role
Yoon Ho Ko, MD, PhD	Uijeongbu St. Mary's Hospital, The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uijeongbu St. Mary's hospital, the Catholic university of Korea	Recruiting	Uijeongbu-si	Gyounggido	480-130	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018655	Lymphocyte Count

Ancestor Terms

ID	Term
D007958	Leukocyte Count
D001772	Blood Cell Count
D002452	Cell Count
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided