NSCLCNCT02283021
Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)
An observational study of NSCLC, run by Hadassah Medical Organization.
Trial summary
Calcium is an extremely important ion used in our body for many processes. One of its tasks is to control gene expression. Cells intake calcium from their surroundings though special calcium channels located on the surface membranes of the cells. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC
- What is being tested?
- A biopsy sample
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with NSCLC and patients not diagnosed with NSCLC
Who may be able to join
- NSCLC patients
- Patients without NSCLC
- Men or woman between 18-80 years of age
Who cannot join
- Pregnant woman
About this study
Calcium is an extremely important ion used in our body for many processes. One of its tasks is to control gene expression. Cells intake calcium from their surroundings though special calcium channels located on the surface membranes of the cells.
The great many studies on such calcium channels were performed on excitable cells such as muscle, heart or neuronal cells, where the calcium ions are controlled by voltage. Surprisingly, not much is known about the identity of calcium subunits in non-excitable cells like epithelial cells (which compose most of the connective tissue in the body), liver cells, lung cells, immune system cells, etc.
Read more
Recently, the investigators have shown that calcium channels from muscles are, in fact, expressed in T cells of the immune system, where they are used for proliferation. The investigators postulated that probably other cell types, especially cancerous cell types, might be using these subunits similarly.
The aim of this study is to determine the identity and sequence of calcium subunits expressed in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide lung cancer deaths.
Read the detailed description
Initial examination of NSCLC cell lines determined that they express the mRNA of voltage gated calcium subunits, found normally in neurons. Furthermore sequence analysis of these subunits has shown that modifications have occurred.
The aim of the study in NSCLC patients is to sequence and clone the calcium channel subunits expressed in their tumor. Expression and Sequence will be compared between the normal and cancerous lung tissue for each patient.
- Conditions
- NSCLC
- Being tested
- A biopsy sample
- Keywords
- expression of L-type calcium subunits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A biopsy sampleOther
Sample tissue will be obtained from the routine biopsy taken for pathological evaluation. A pathologist will determine which part of the tissue will be forwarded for this study, to avoid any interference with the pathological evaluation.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC Patients | Sample biopsies from normal and cancerous lung tissue. Receives: Other: A biopsy sample | |
| Patients without NSCLC | Sample biopsies from normal lung tissue.Control group. Receives: Other: A biopsy sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression and sequence of calcium channel subunits in NSCLC
mRNA will be extracted from each sample biopsy followed by real time PCR analysis. If any calcium subunit is detected, semi quantitative PCR will be performed, PCR bands will be cloned and sequenced.
Measured: up to 1 month per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadas Lamberg, PhD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283021
- Sponsor's protocol ID
- CALCIUM-HMO-CTIL
- Status last verified
- Aug 2015
- First submitted
- 5 Oct 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)
- ClinicalTrials.gov ID
- NCT02283021
- Acronym / sponsor ID
- CALCIUM-HMO-CTIL
- Conditions
- NSCLC
- Keywords
- expression of L-type calcium subunits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 5 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.
Calcium is an extremely important ion used in our body for many processes. One of its tasks is to control gene expression. Cells intake calcium from their surroundings though special calcium channels located on the surface membranes of the cells.
The great many studies on such calcium channels were performed on excitable cells such as muscle, heart or neuronal cells, where the calcium ions are controlled by voltage. Surprisingly, not much is known about the identity of calcium subunits in non-excitable cells like epithelial cells (which compose most of the connective tissue in the body), liver cells, lung cells, immune system cells, etc.
Recently, the investigators have shown that calcium channels from muscles are, in fact, expressed in T cells of the immune system, where they are used for proliferation. The investigators postulated that probably other cell types, especially cancerous cell types, might be using these subunits similarly.
The aim of this study is to determine the identity and sequence of calcium subunits expressed in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide lung cancer deaths.
Detailed description
Initial examination of NSCLC cell lines determined that they express the mRNA of voltage gated calcium subunits, found normally in neurons. Furthermore sequence analysis of these subunits has shown that modifications have occurred.
The aim of the study in NSCLC patients is to sequence and clone the calcium channel subunits expressed in their tumor. Expression and Sequence will be compared between the normal and cancerous lung tissue for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC Patients | – | Other: A biopsy sampleSample biopsies from normal and cancerous lung tissue. |
| Patients without NSCLC | – | Other: A biopsy sampleSample biopsies from normal lung tissue.Control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with NSCLC and patients not diagnosed with NSCLC
Key inclusion criteria (3 listed)
- NSCLC patients
- Patients without NSCLC
- Men or woman between 18-80 years of age
Key exclusion criteria (1 listed)
- Pregnant woman
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 |
|---|---|---|
| A biopsy sampleSample tissue will be obtained from the routine biopsy taken for pathological evaluation. A pathologist will determine which part of the tissue will be forwarded for this study, to avoid any interference with the pathological evaluation. | Other | NSCLC Patients, Patients without NSCLC |
Primary outcome
mRNA expression and sequence of calcium channel subunits in NSCLC
Time frame: up to 1 month per patient
mRNA will be extracted from each sample biopsy followed by real time PCR analysis. If any calcium subunit is detected, semi quantitative PCR will be performed, PCR bands will be cloned and sequenced.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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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.
Hadas Lamberg, PhD study director
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Hadassah Medical Organization.
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 3 inclusion and 1 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
mRNA expression and sequence of calcium channel subunits in NSCLC (time frame: up to 1 month per patient). 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 20 Aug 2015.