NCT00568282

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

10.1 years

First QC Date

December 4, 2007

Last Update Submit

June 17, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

phlebotomyPROCEDURE

Standard of care

Also known as: blood draw

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • no known prior or active malignancy
  • ability to sign informed consent

You may not qualify if:

  • \. pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

PhlebotomyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Heather A. Wakelee

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

February 1, 2007

Primary Completion

March 8, 2017

Study Completion

July 13, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations

US(1)