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Completed

NCT Number: NCT01510405

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tissue collection

Other

Tissue sample collection

Other names: Frozen tissue specimens will be stored at -80

Primary outcomes

  1. Correlation between the Phosphoproteomic expression pattern of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 (PLK1)

    Time frame: 2 years

    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.)

Secondary outcomes

  1. Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns

    Time frame: 2 years

    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. Time to Disease Recurrence

    Time frame: 2 years

    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

  3. Lung Cancer Specific Survival

    Time frame: 2 years

    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.

  4. Overall Survival

    Time frame: 2 Years

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2012
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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