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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733252
Recruitment Status : Withdrawn (Low interest)
First Posted : August 13, 2008
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date August 12, 2008
First Posted Date August 13, 2008
Last Update Posted Date October 2, 2015
Study Start Date April 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2010)
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. ]
Original Primary Outcome Measures
 (submitted: August 12, 2008)
Correlation of optical coherence tomography images of the airway with airway histology
Change History Complete list of historical versions of study NCT00733252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease
Official Title 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 Observational
Study Design 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
  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • Nonmalignant Neoplasm
  • Precancerous Condition
Intervention
  • 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 Groups/Cohorts 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 Withdrawn
Actual Enrollment
 (submitted: February 17, 2011)
0
Original Estimated Enrollment
 (submitted: August 12, 2008)
10
Actual Study Completion Date February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00733252
Other Study ID Numbers CASE1508
P30CA043703 ( U.S. NIH Grant/Contract )
CASE1508 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-1508-CC483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor Case Comprehensive Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Rana Hejal, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date October 2015