NCT00733252

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

August 12, 2008

Last Update Submit

October 1, 2015

Conditions

Lung CancerMalignant MesotheliomaMetastatic CancerNonmalignant NeoplasmPrecancerous Condition

Keywords

non-small cell lung cancersmall cell lung cancerbenign respiratory tract neoplasmlung papillomarecurrent respiratory papillomatosissquamous lung dysplasiamalignant mesotheliomapulmonary carcinoid tumorlung metastases

Outcome Measures

Primary Outcomes (1)

  • Correlation of optical coherence tomography images of the airway with airway histology

    This study will involve discarded tissue from 10 subjects with pathology specimens over one year.

Interventions

bronchoscopic and lung imaging studiesPROCEDURE

Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.

diagnostic bronchoscopyPROCEDURE

Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.

histopathologic examinationPROCEDURE

All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

optical coherence tomographyPROCEDURE

Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

DISEASE CHARACTERISTICS: * Undergoing pneumonectomy or lobectomy for malignant or benign lung processes PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Lung NeoplasmsMesothelioma, MalignantNeoplasm MetastasisNeoplasmsPrecancerous ConditionsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaRecurrent respiratory papillomatosis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Rana Hejal, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

US(1)