Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer
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Purpose
RATIONALE: Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.
PURPOSE: This research studies protein in tumor samples from patients with non-small cell lung cancer.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: staining method |
| Study Type: | Observational |
| Official Title: | Evaluation of a Novel Molecular NSCLC Classification System |
- Validation of a novel 4-protein signature's ability to subtype NSCLC [ Designated as safety issue: No ]
- NSCLC misclassification rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 261 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, CALGB 9761.
Secondary
- To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
OUTLINE: Archived tumor tissue samples are marked for regions appropriate for incorporation into tissue microarray (TMA) and incubated with a cocktail of primary antibodies. Slides are then stained and a series of high-resolution monochromatic images are captured by the PM-2000 ™ microscope of each protein. Score of each specific protein is then calculated by Automated Quantitative Analysis (AQUA).
A board-certified pathologist with a clinical focus in lung cancer reviews the hematoxylin and eosin (H&E) and immunohistochemistry (IHC) slides and indicates the specific non-small cell lung cancer subtype. Results are then compared with the primary reference subtype captured by CALGB-9761 database.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must have been registered on CALGB-9761
- Stage I disease
- Treatment-naive patients
- A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01415739 History of Changes |
| Other Study ID Numbers: | CDR0000706383, CALGB-151102 |
| Study First Received: | August 11, 2011 |
| Last Updated: | August 11, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IA non-small cell lung cancer stage IB non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013