Lung CancerNCT02301858
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
A study testing Genome analysis of tissue samples. in people with Lung Cancer and Primary Tumor, run by Janna Berg at 1 site in Norway.
Trial summary
The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Primary Tumor, Metastases
- What is being tested?
- Genome analysis of tissue samples.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2013to Dec 2025
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastasizing lung cancer where further treatment is still applicable.
Who cannot join
- Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
- Patients where further cancer treatment is no longer applicable.
- Patients with cognitive impairment.
- Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.
Trial locations and contacts
1 site in 1 country.
About this study
The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.
Read the detailed description
The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.
- Conditions
- Lung Cancer, Primary Tumor, Metastases
- Being tested
- Genome analysis of tissue samples.
- Keywords
- molecular pathology, functional genomics, lung cancer, primary tumor, metastases
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome analysis of tissue samples.Genetic
Genome analysis of tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Other | Genome analysis of tissue samples. Receives: Genetic: Genome analysis of tissue samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung
We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations.
Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janna Berg
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor-investigator, Janna Berg, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301858
- Sponsor's protocol ID
- SIV 9743
- Status last verified
- Jan 2023
- First submitted
- 4 Aug 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
- ClinicalTrials.gov ID
- NCT02301858
- Acronym / sponsor ID
- SIV 9743
- Conditions
- Lung Cancer, Primary Tumor, Metastases
- Keywords
- molecular pathology, functional genomics, lung cancer, primary tumor, metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Janna BergUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Dec 2013
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2014 (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 project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.
Detailed description
The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Other | Genetic: Genome analysis of tissue samples.Genome analysis of tissue samples. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with metastasizing lung cancer where further treatment is still applicable.
Key exclusion criteria (4 listed)
- Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
- Patients where further cancer treatment is no longer applicable.
- Patients with cognitive impairment.
- Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.
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 |
|---|---|---|
| Genome analysis of tissue samples.Genome analysis of tissue samples. | Genetic | Study arm |
Primary outcome
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung
Time frame: 5 years
We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations. Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genome analysis of tissue samples. in people with Lung Cancer and Primary Tumor, run by Janna Berg at 1 site in Norway.
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 4 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 23 Jan 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 Norway. 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?
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?
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung (time frame: 5 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 23 Jan 2023.