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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02283021
Other study ID # CALCIUM-HMO-CTIL
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 5, 2014
Last updated August 19, 2015
Start date January 2015
Est. completion date January 2018

Study information

Verified date August 2015
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date January 2018
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- NSCLC patients

- Patients without NSCLC

- Men or woman between 18-80 years of age

Exclusion Criteria:

- Pregnant woman

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
A biopsy sample
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 1 month per patient No
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