Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer

The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models the proteomic expression profile associated with exposure to Aurora and Polo-like kinase inhibitors. The identification of proteomic expression patterns in patients with NSCLC would be an important step in defining the possible role of these agents as potential targeted therapies for this clinically important disease. This study proposes to evaluate resected non-small cell lung cancer specimens for these proteomic expression profiles.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: Tissue Collection

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have presumed lung cancer

Description

Inclusion Criteria:

• Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer
• Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
• Age ≥ 18 years.
• Subject meets criteria for thoracic surgery as determined by the thoracic surgeon.
• Able to provide written informed consent.

Exclusion Criteria:

• Subjects undergoing or who have undergone thoracic surgery for metastatic disease from other primary sources such as colorectal cancer, sarcoma, melanoma, breast cancer, bladder cancer, prostate cancer, esophageal cancer, pancreatic cancer, or gastric cancer will be excluded.
• Subjects who have received prior preoperative lung cancer anticancer therapy will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
40 Participants; Participants undergoing or who have undergone thoracic surgery for presumed lung cancer with a wedge resection, lobectomy, bilobectomy, segmentectomy and/ or pneumonectomy thoracic surgical operation.	Other: Tissue Collection; Tissue sample collection; Other Names: Frozen tissue specimens will be stored at -80

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the Phosphoproteomic expression pattern of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 (PLK1)	Correlation of phosphoproteomic expression patterns of specific substrates of Aurora kinase A and/or Polo-like kinase 1 and disease-free survival in surgically resected NSCLC. (Disease-free survival is defined as the time from surgical resection until the first documentation of disease recurrence or death.)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns	To establish and validate a technology for quantitatively determining global phosphoproteomic expression profiles in surgically resected NSCLC specimens and To correlate global phosphoproteomics expression patterns with time to disease recurrence, lung cancer-specific survival and overall survival.	2 years
Time to Disease Recurrence	Time to disease recurrence: Correlation of phosphoroteomic expression patterns of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 and time to disease recurrence defined as the time from surgical resection until the first documented evidence of disease recurrence	2 years
Lung Cancer Specific Survival	Correlation of phosphoproteomic expression patterns of specific substrates of Aurora kinase A and/or Polo-kinase 1 and lung cancer specific survival defined as the time from surgical resection until death from lung cancer. For subjects who have died from other causes than lung cancer, time to death will be censored at the time of death from causes other than lung cancer.	2 years
Overall Survival	Correlation of phosphproteomic expression patters of specific substrates of Aurora kinase A and/or Polo-like kinase 1 and overall survival defined as the time from surgical resection until death due to any cause. For subjects who do not yet die, time to death will be censored at the time of last contact.	2 Years

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: James R Rigas, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimated): January 16, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer.; The following procedures are allowed: Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D1026