Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

November 21, 2023 updated by: Fabien Maldonado, Vanderbilt-Ingram Cancer Center

Molecular Predictors of Lung Cancer Behavior

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
  • To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.

OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.

Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vanderbilt Ingram Clinical Trials Information Program
  • Phone Number: 1-800-811-8480

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • VICC Clinical Trials Information Program
          • Phone Number: 800-811-8480
          • Email: cip@vanderbilt.edu
        • Principal Investigator:
          • Pierre Massion, MD
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Veterans Affairs Medical Center - Nashville
        • Principal Investigator:
          • Pierre Massion, MD
        • Contact:
          • Research Office
          • Phone Number: 615-873-8066
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People who may have lung cancer.

Description

Inclusion Criteria:

-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

Exclusion Criteria:

  • Inability to provide informed consent
  • Minors
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sample Collection
Genetic: comparative genomic hybridization
Collection of sputum, blood, urine, and a small amount of lung tissue.
Genetic: gene expression microarray analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
Genetic: proteomic profiling analysis
Collection of sputum, blood, urine, and a small amount of lung tissue.
Other: biologic sample preservation procedure
Collection of sputum, blood, urine, and a small amount of lung tissue.
Procedure: nasal brushing
Using a brush, superficial cells are removed from the nose.
Procedure: Blood draw
Venous blood will be collected
Procedure: Urine collection
Subjects will be asked to provide a urine specimen.
Procedure: sputum sample
Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
Procedure: fluorescence bronchoscopy with airway biopsy
A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.
Procedure: fine needle aspiration of the lung
A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.
Procedure: thoracentesis
A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantitate the molecular changes during lung cancer development
Time Frame: After collection of designated samples

As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up.

Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.
After collection of designated samples

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a method to diagnose and stage pre-invasive and invasive lesions
Time Frame: After collection of designated samples
Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis
After collection of designated samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Fabien Maldonado, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC THO 0398
  • P30CA068485 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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