Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)

NSCLC Clinical Trial

Official title:

Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02283021
• Other study ID #: CALCIUM-HMO-CTIL
• 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

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NSCLC

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