NCT02507778

Brief Summary

The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

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

July 14, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

July 14, 2015

Last Update Submit

September 22, 2016

Conditions

Lung Cancer

Keywords

LungCancerBiomarkersEarly detectionCirculating tumor cell

Outcome Measures

Primary Outcomes (1)

  • Circulating tumor cells (CTCs) before and after the procedure.

    In this study we will use for CTC counting the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM).

    1 day

Study Arms (1)

biopsy

OTHER

needle will be inserted before and after biopsy and will measure circulating tumor cells.

Device: CellCollectorTM (Gilupi, Germany) needle

Interventions

CellCollectorTM (Gilupi, Germany) needleDEVICE

needle will be inserted before and after biopsy and will measure circulating tumor cells.

biopsy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of lung cancer
  • Patients are designated to undertake biopsy
  • Able and willing to participate in this study
  • Availability of a signed informed consent

You may not qualify if:

  • Any recent non-lung cancer in the recent 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsNeoplasmsNeoplastic Cells, Circulating

Interventions

Needles

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Nir Peled, MD PhD FCCP

    nirp@clalit.org.il

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Peled, MD PhD FCCP

CONTACT

nirp@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 24, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2019

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)