Study of Changes of Lymphocyte Subsets in Chemotherapy Co... | NCT02202655

Studies
Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

NCT02202655

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2014Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Not provided

Countries

China

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

Jul 2014

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 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Jun 24, 2014

First Submission Date that Met QC Criteria

Jul 28, 2014

First Posted Date

Jul 29, 2014Estimated

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

Jul 28, 2014

Last Update Posted Date

Jul 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yingmin Ma, Vice President of the Beijing chaoyang hospital, Beijing Chao Yang HospitalPrincipal Investigator

Lead Sponsor

Beijing Chao Yang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Detailed Description

patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the changes of patients' lymphocyte subsets in chemotherapy courses.		up to cycle 4 day 9

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer .
Functional Status Score (PS) ≧ 70.
The first time for chemotherapy .
A Written Informed Consent.

Exclusion Criteria:

Merging other tumors.
HAve autoimmune diseases.
AIDS

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with non-small cell lung cancer who accept chemotherapy for the first time are acceptable.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
qian wang, master	Contact	18810252602		wenqian.3334444@163.com

Overall Officials

Name	Affiliation	Role
yingmin ma	Vice President of the Beijing chaoyang hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WangQian	Recruiting	Beijing	Beijing Municipality	100020	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided