Non-Small Cell Lung CancerNCT01510405
Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Tissue Collection
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have presumed lung cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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
- Being tested
- Tissue Collection
- 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.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue CollectionOther
Also called Frozen tissue specimens will be stored at -80
Tissue sample collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin Dragnev, Dartmouth-Hitchcock Medical Center
- Investigators
- James R Rigas, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510405
- Sponsor's protocol ID
- D1026
- Status last verified
- Jul 2023
- First submitted
- 6 Jan 2012
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01510405
- Acronym / sponsor ID
- D1026
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40 Participants | – | Other: Tissue CollectionParticipants undergoing or who have undergone thoracic surgery for presumed lung cancer with a wedge resection, lobectomy, bilobectomy, segmentectomy and/ or pneumonectomy thoracic surgical operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have presumed lung cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue CollectionAlso: Frozen tissue specimens will be stored at -80Tissue sample collection | Other | 40 Participants |
Primary outcome
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.)
4 secondary outcomes
Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns
Time frame: 2 years
Time to Disease Recurrence
Time frame: 2 years
Lung Cancer Specific Survival
Time frame: 2 years
Overall Survival
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Rigas, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the Phosphoproteomic expression pattern of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 (PLK1) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.