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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01510405
First received: January 6, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Non-Small Cell Lung Cancer
Other: Tissue Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Correlation between the Phosphoproteomic expression pattern of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 (PLK1) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Time to Disease Recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Lung Cancer Specific Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Frozen tissue specimens will be stored at -80

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have presumed lung cancer

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510405

Contacts
Contact: James R. Rigas, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: James R Rigas, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Principal Investigator: James R Rigas, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: James R Rigas, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01510405     History of Changes
Other Study ID Numbers: D1026
Study First Received: January 6, 2012
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
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:
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 July 26, 2014