Completed

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

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What is being collected

Genetic Data

+ other Data
+ procedure Data
Collected from today forward - Prospective
Genetic
Other
Procedure
Who is being recruted

Lung Cancer

Over 18 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: February 2004

See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

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. OBJECTIVES: Primary * Determine, prospectively, whether serum proteomic profiling can predict the presence of primary non-small cell lung cancer in patients with clinically suspicious stage I lung lesions who are undergoing lung resection. Secondary * Correlate the serum proteomic profile with pathologic nodal status and histopathologic features of primary lung cancer in these patients. * Correlate the initial and follow-up serum proteomic profile with overall and cancer-specific survival of these patients. * Correlate changes in the proteomic profile (preoperative to postoperative) with overall and cancer-specific survival of these patients. Tertiary * Determine whether novel molecular strategies can predict the presence of lung cancer and/or the biologic behavior of an individual cancer in these patients.

Official TitleUse Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Cancer
Criteria
9 inclusion criteria required to participate
Patient must be ≥18 years of age
Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion
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
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

Show More Criteria

3 exclusion criteria prevent from participating
Patient has undergone previous lung resection within the preceding 30 days
Patient has received prior chemotherapy or radiotherapy
Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Patients undergo lung resection. Patients also undergo preoperative and postoperative collection of whole blood and serum for proteomic profiling using surface-enhanced laser desorption/ionization-time of flight mass spectrometry. A lung tissue biopsy taken at surgery is also analyzed. Patients are followed at 60-90 days and then annually for 2-5 years.
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 73 locations
Suspended
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, United StatesSee the location
Suspended
John Muir/Mount Diablo Cancer Center - Concord CampusConcord, United States
Suspended
City of Hope Comprehensive Cancer CenterDuarte, United States
Suspended
Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, United States
Completed73 Study Centers