NCT01570855

Brief Summary

The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

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

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

March 19, 2012

Last Update Submit

April 25, 2016

Conditions

Lung Cancer

Keywords

Lung cancerchemosensitivity

Outcome Measures

Primary Outcomes (1)

  • Tumor size

    Tumor response will be evaluated (progression/regression) by CT scan at 3 months from therapy start. Clinical response to chemotherapy of lung cancer tumor cells versus lung cancer stem cells to standard of care chemo drugs will be evaluated and correlated to predicted drug by ex vivo assay.

    3 months

Eligibility Criteria

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

Patients who have a suspected or confirmed diagnosis of lung cancer, and who are scheduled to have a diagnostic fine needle aspiration, core needle biopsy, or excisional biopsy of the lung lesion.

You may qualify if:

  • suspected or confirmed diagnosis of lung cancer
  • undergoing a fine needle aspiration, core biopsy, or excisional biopsy for diagnosis.
  • Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
  • Patient must be at least 18 years of age
  • Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

You may not qualify if:

  • Patient pathology shows benign pathology for sample submitted
  • Patient is not indicated to receive chemotherapy for their disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pier P. Claudio, M.D., Ph. D

    Marshall University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Biochemistry and Microbiology

Study Record Dates

First Submitted

March 19, 2012

First Posted

April 4, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

US(1)