CompletedNot applicableNCT00077324
Official study title

Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions

Study summary

RATIONALE: Evaluating specific proteins in the blood may be an effective and noninvasive procedure to help doctors determine if a patient has early non-small cell lung cancer. PURPOSE: This clinical trial is studying proteomic profiling to see how well it works in diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious (abnormal) stage I lung lesions.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedproteomic profiling and surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?73 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Genetic: proteomic profiling; Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry; Procedure: biopsy; Procedure: surgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Patient must be ≥18 years of age. 2. Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion. 3. Patient must have pre-operative imaging procedures within 60 days prior to the date of the lung resection: Helical CT scan of the chest and CT scan of the upper abdomen, including the liver and adrenal glands (with or without IV contrast), as clinically indicated. The helical CT must rule out metastatic disease in the liver and adrenal glands. 4. Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed. 5. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient PRIOR to registration and any study-related procedures being performed. 6. If patient is a survivor of a prior cancer, the following criteria are met: 1. Patient has undergone potentially curative therapy for all prior malignancies, 2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), 3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Reasons someone may not be able to joinExclusion criteria

1. Patient has undergone previous lung resection within the preceding 30 days. 2. Patient has received prior chemotherapy or radiotherapy. 3. Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama
  • John Muir/Mount Diablo Cancer Center - Concord CampusConcord, California
  • City of Hope Comprehensive Cancer CenterDuarte, California
  • Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California
  • Veterans Affairs Medical Center - Loma Linda (Pettis)Loma Linda, California
  • Sutter Cancer Center at Roseville Medical CenterRoseville, California
  • Sutter Cancer CenterSacramento, California
  • John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California
  • Praxair Cancer Center at Danbury HospitalDanbury, Connecticut
  • George Washington University Medical CenterWashington D.C., District of Columbia
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
  • Winship Cancer Institute of Emory UniversityAltanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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