NCT02283021

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

October 5, 2014

Last Update Submit

August 19, 2015

Conditions

Keywords

expression of L-type calcium subunits

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

NSCLC Patients

Sample biopsies from normal and cancerous lung tissue.

Other: A biopsy sample

Patients without NSCLC

Sample biopsies from normal lung tissue.Control group.

Other: A biopsy sample

Interventions

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.

NSCLC PatientsPatients without NSCLC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with NSCLC and patients not diagnosed with NSCLC

You may qualify if:

  • NSCLC patients
  • Patients without NSCLC
  • Men or woman between 18-80 years of age

You may not qualify if:

  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lung specimen biospsies are routinely taken from NSCLC patients and sent to pathological evaluation. We will obtain small samples from these biopsies from the pathologist, which are normally discarded. mRNA will be extracted from these samples.

Study Officials

  • Hadas Lamberg, PhD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2014

First Posted

November 5, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

August 20, 2015

Record last verified: 2015-08