Lung CancerNCT02161523
The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation
An observational study of Lung Cancer, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 1 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with non small cell lung carcinoma that need a surgery without connection to this experiment
Who may be able to join
- Patient with non small cell lung carcinoma
Who cannot join
- none
About this study
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.
Read more
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.
- Conditions
- Lung Cancer
- Keywords
- mast cells, lung cancer, cancer associated fibroblasts (CAF)
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start1 Jul 2014
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161523
- Sponsor's protocol ID
- 0059-14-MMC
- Other IDs
- 0059-14-MMC
- Status last verified
- Mar 2018
- First submitted
- 10 Jun 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation
- ClinicalTrials.gov ID
- NCT02161523
- Acronym / sponsor ID
- 0059-14-MMC
- Conditions
- Lung Cancer
- Keywords
- mast cells, lung cancer, cancer associated fibroblasts (CAF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with non small cell lung carcinoma that need a surgery without connection to this experiment
Key inclusion criteria (1 listed)
- Patient with non small cell lung carcinoma
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels
Time frame: 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.