Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization of Methylation Patterns in Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373917
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nucleix Ltd.

Brief Summary:
In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Condition or disease
Lung Cancer

Detailed Description:
Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Methylation Patterns in Lung Cancer
Actual Study Start Date : February 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort
study group
patient who in the biopsy showed lung cancer
control group
patient who in the biopsy showed not to have lung cancer



Primary Outcome Measures :
  1. Characterization of Methylation Patterns in lung Cancer [ Time Frame: two years ]
    Collecting and analyzing samples


Biospecimen Retention:   Samples Without DNA
  1. Blood samples
  2. Sputum samples
  3. saliva samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who come to the medical center for the diagnosis of lung cancer.
Criteria

Inclusion Criteria:

  • Patients with suspected lung tumor

Exclusion Criteria:

  • Patients who have active disease other than lung cancer during the sample collecting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373917


Contacts
Layout table for location contacts
Contact: Eilon Ganor, MD 9723-7674840 Elon@nucleix.com

Locations
Layout table for location information
Israel
Sha'are Tzedaek Medical Center Recruiting
Jerusalem, Israel
Contact: Gabriel Izbicki, MD       izbicki@szmc.org.il   
Principal Investigator: Gabriel Izbicki, MD         
Sponsors and Collaborators
Nucleix Ltd.
Investigators
Layout table for investigator information
Study Director: Eilon Ganor, MD Nucleix Ltd.
Layout table for additonal information
Responsible Party: Nucleix Ltd.
ClinicalTrials.gov Identifier: NCT02373917    
Other Study ID Numbers: Lung-RND-001
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases