Identification of Circulating Tumor Cells in the Peripher... | NCT00568282

Studies
Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients

NCT00568282

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jun 22, 2022Actual

Enrollment

219Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

phlebotomy

Countries

United States

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

ID	Type	Description
96710	Other Identifier	Stanford University Alternate IRB Approval Number
LUN0017	Other Identifier	Stanford University
4086	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007Actual

Primary Completion Date

Mar 8, 2017Actual

Completion Date

Jul 13, 2021Actual

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 6, 2007Estimated

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

Jun 17, 2022

Last Update Posted Date

Jun 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients.

Detailed Description

The purpose of this study is to determine whether we can identify lung cancer cells circulating in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells such as CD44 and epithelial specific antigen.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

219Actual

Name	Type	Description	Arm Group Labels	Other Names
phlebotomy	Procedure	Standard of care		blood draw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells.		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Inclusion Criteria:Inclusion Criteria (Cases):

Advanced stage (IIIB with malignant effusion or IV) histologically or cytologically confirmed NSCLC
Patients must be newly diagnosed (untreated) or have evidence of disease progression at the time of sample collection
ability to sign informed consent
at least 18 years of age

Inclusion Criteria (Controls):

no known prior or active malignancy
ability to sign informed consent
at least 18 years of age Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years

2. pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced stage NSCLC who are either newly diagnosed, or who have evidence of disease progression.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather A. Wakelee	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018962	Phlebotomy
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided