Lung CancerNCT01619501
Dysregulation of the C/EBPa Pathway in Human Lung Cancer and Search for New Biomarkers and/or Therapeutic Targets
An observational study of Lung Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The overall goal of this research is to enhance the investigators understanding of the pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Apr 2012to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Archived samples from the Department of Pathology (for IHC, FISH) and the Tissue Repository (for fresh tumor samples) at NUHS
Who may be able to join
- Patients with lung cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Nationa University Hospital
Singapore
Ross Soo, +65 6779 5555
Ross Soo
About this study
The overall goal of this research is to enhance the investigators understanding of the pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets. By comparing gene expression between normal lung tissue and tumors growing in lung-specific C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have validated this observation in human lung cancer, implicating the investigators KO mice are an effective discovery tool for lung cancer research. Through similar approaches, the investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators will proceed to define the clinical relevance of the SHH pathway and the other newly-discovered molecular aberrations, by analyzing their expression and correlate it to C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful correlates that could be used in diagnosis and treatment of lung cancer, as well as identify new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.
This proposal seeks to test the hypothesis that pathways which are dysregulated in lung tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to identify genes involved in human lung cancer pathogenesis.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the C/EBPa-Bmi-1 axis in human lung cancer
Tissue microarrays will be created from the lung tumours. Only resection specimens will be used for TMA construction, and small, limited biopsies will not be used. Tissue punches of 1.5mm in diameter will be cut from the blocks (2 punches per tumour, 1 punch for normal lung). Hence the rest of the tumour block is not used, preserving most of the tumour tissue in the tissue blocks, for future diagnostic use.
Secondary outcomes (2)
Validate the relevance of the C/EBPa-SHH pathway in human NSCLC
We will stain the human lung cancer specimens with antibodies against Gli1 (the major effector of the SHH pathway), Patched-1, Patched-2 and Smoothened (the receptors of the pathway), Sonic, Indian and Desert Hedgehog (the ligands of the pathway), and Cyclin D, Cyclin E, and Myc (target genes of the pathway).Interestingly, the SHH pathway has been recently associated to primary cilia (PC), where its specific role is highly controversial. Genetic defects affecting PC result in a myriad of pathological instances, including lung pathologies
Identify new downstream targets of C/EBPa in murine lung cancer and test their involvement in human pathogenesis
RNA microarray analysis will be performed by Dr. Levantini at the BIDMC (Tenen lab, Boston), to compare gene expression between C/EBPa-/- pulmonary tumors and the neighboring normal murine tissue. The mouse MOE430A gene chip from Affymetrix will be utilized, as recently published (Basseres et al., MCB 2006). Single cell suspension will be depleted by FACS for endothelial and hematopoietic markers (CD45, Ter119, CD31). Purified populations will then undergo cRNA synthesis followed by hybridization to the Affymetrix gene chips. The top 10,000 genes will be selected based on their ranking.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619501
- Sponsor's protocol ID
- 2012/00117
- Status last verified
- Dec 2013
- First submitted
- 4 Apr 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of the C/EBPa Pathway in Human Lung Cancer and Search for New Biomarkers and/or Therapeutic Targets
- ClinicalTrials.gov ID
- NCT01619501
- Acronym / sponsor ID
- 2012/00117
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 14 Jun 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 overall goal of this research is to enhance the investigators understanding of the pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets. By comparing gene expression between normal lung tissue and tumors growing in lung-specific C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have validated this observation in human lung cancer, implicating the investigators KO mice are an effective discovery tool for lung cancer research. Through similar approaches, the investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators will proceed to define the clinical relevance of the SHH pathway and the other newly-discovered molecular aberrations, by analyzing their expression and correlate it to C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful correlates that could be used in diagnosis and treatment of lung cancer, as well as identify new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.
This proposal seeks to test the hypothesis that pathways which are dysregulated in lung tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to identify genes involved in human lung cancer pathogenesis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Archived samples from the Department of Pathology (for IHC, FISH) and the Tissue Repository (for fresh tumor samples) at NUHS
Key inclusion criteria (1 listed)
- Patients with lung cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define the C/EBPa-Bmi-1 axis in human lung cancer
Tissue microarrays will be created from the lung tumours. Only resection specimens will be used for TMA construction, and small, limited biopsies will not be used. Tissue punches of 1.5mm in diameter will be cut from the blocks (2 punches per tumour, 1 punch for normal lung). Hence the rest of the tumour block is not used, preserving most of the tumour tissue in the tissue blocks, for future diagnostic use.
2 secondary outcomes
Validate the relevance of the C/EBPa-SHH pathway in human NSCLC
Identify new downstream targets of C/EBPa in murine lung cancer and test their involvement in human pathogenesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
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 Lung Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Dec 2013. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Soo (+65 6779 5555, Ross_Soo@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the C/EBPa-Bmi-1 axis in human lung cancer. 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 11 Dec 2013.