NCT02373917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
683

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

6.2 years

First QC Date

February 22, 2015

Last Update Submit

May 3, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Characterization of Methylation Patterns in lung Cancer

    Collecting and analyzing samples

    two years

Study Arms (2)

study group

patient who in the biopsy showed lung cancer

control group

patient who in the biopsy showed not to have lung cancer

Eligibility Criteria

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

Participants who come to the medical center for the diagnosis of lung cancer.

You may qualify if:

  • Patients with suspected lung tumor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sha'are Tzedaek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • Gaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan.

    PMID: 33122336DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Blood samples 2. Sputum samples 3. saliva samples

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eilon Ganor, MD

    Nucleix Ltd.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

IL(1)