Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

This study has been withdrawn prior to enrollment.

(Low interest)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00733252

First received: August 12, 2008

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2008

Last Updated Date

March 21, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation of optical coherence tomography images of the airway with airway histology [ Time Frame: This study will involve discarded tissue from 10 subjects with pathology specimens over one year. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Correlation of optical coherence tomography images of the airway with airway histology [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00733252 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Official Title ^ICMJE

Optical Coherence Tomography of Human Airways

Brief Summary

RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.

PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed Description

OBJECTIVES:

Correlate optical coherence tomography images of the airway with airway histology.
Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.

OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Fresh Bronchi from 10 subjects undergoing pneumonectomy or lobectomy for malignant and benign processes will be obtained from the UHCMC Pathology Department as discarded tissue from fresh specimens

Sampling Method

Probability Sample

Study Population

primary care clinic

Condition ^ICMJE

Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Nonmalignant Neoplasm
Precancerous Condition

Intervention ^ICMJE

Procedure: bronchoscopic and lung imaging studies
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
Procedure: diagnostic bronchoscopy
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
Procedure: histopathologic examination
All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
Procedure: optical coherence tomography
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00733252

Other Study ID Numbers ^ICMJE

CASE1508, P30CA043703, CASE1508, CASE-1508-CC483

Has Data Monitoring Committee

Yes

Responsible Party

Case Comprehensive Cancer Center

Study Sponsor ^ICMJE

Case Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Rana Hejal, MD

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Information Provided By

Case Comprehensive Cancer Center

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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