NCT02161523

Brief Summary

In addition to their role in allergic inflammation, mast cells are often found at the site of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors. The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis. In this work, we are interested to determine the factors in lung cancer microenvironment that attribute to mast cell activation. Beside the tumor cells themselves, the cancer microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different feature compared to normal fibroblasts (NFs). In this work we are interested to determine whether CAF cells derived from lung tumors, together with the lung cancer cells, or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/ or to release various cytokines and chemokines. For this propose, during surgery of patients with lung cancer, we will take unnecessary sample from the cancer and from normal area for purification of CAF or normal fibroblast cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be collected for determine degranulation and cytokine release from these mast cells.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

June 10, 2014

Last Update Submit

March 21, 2018

Conditions

Keywords

mast cells, lung cancer, cancer associated fibroblasts (CAF)

Outcome Measures

Primary Outcomes (1)

  • Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels

    1-2 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with non small cell lung carcinoma that need a surgery without connection to this experiment

You may qualify if:

  • Patient with non small cell lung carcinoma

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy from lung tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 11, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 22, 2018

Record last verified: 2018-03