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

NCT01510405 | Completed DMC

• 1 other identifier: D1026
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns

  2 years

• Time to Disease Recurrence

  2 years

• Lung Cancer Specific Survival

  2 years

• Overall Survival

  2 Years

Study Arms (1)

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

Interventions

Tissue Collection OTHER

Tissue sample collection

Also known as: Frozen tissue specimens will be stored at -80

40 Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have presumed lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• James R Rigas, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Hematology-Oncology

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 16, 2012
• Study Start: July 1, 2010
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)