the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.NCT01921699
Macrophages Effect on Chemoresistance
A study testing taking blood samples from healthy people in people with the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy., run by Rambam Health Care Campus.
Trial summary
Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been postulated as being involved in the progression of cancer. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.
- What is being tested?
- taking blood samples from healthy people
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Sep 2013
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy people
Who cannot join
- refusal to participate
About this study
Official title: Impact of Macrophages on De-Novo Chemoresistance of Adenocarcinoma Cells
Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been postulated as being involved in the progression of cancer.
Based on our preliminary findings and on published data we hypothesized that macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells during chemotherapy.
Read more
The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of Pancreatic ductal adenocarcinoma (PDA).
methods:
- The human PDA cell line Panc1 will be grown in suitable conditions.
- Macrophages will be produced by incubating mononuclear cells from the blood of healthy donors in medium with M-CSF for 7 days.
- TAMs will be generated by culturing these macrophages with tumor-culture conditioning medium (TCCM) of PDA Cells for an additional 72 hours.
- Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to macrophages CM.
- Cell proliferation will be quantified by light microscopy and by an XTT Cell Proliferation Assay Kit.
- Being tested
- taking blood samples from healthy people
- Keywords
- macrophages, adenocarcinoma, chemoresistance
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking blood samples from healthy peopleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| irrelevant | Other | Not described Receives: Procedure: taking blood samples from healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
proliferation and migration of PANC1 cell line in the tested groups.
the macrophages will be isolated from the blood we'll get from the healthy volunteers. the outcome measure is related to the basic research and not clinical so there's no symptom/outcome related to the participants.
Measured: one day to get the blood samples, and a year after that to complete the basic research
Secondary outcomes (1)
To determine whether direct cell-to-cell interaction or soluble factors participate in MIC.
Measured: a year from obtaining the blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHOROOK NA'ARA MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921699
- Sponsor's protocol ID
- pending
- Other IDs
- pending
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Macrophages on De-Novo Chemoresistance of Adenocarcinoma Cells
- ClinicalTrials.gov ID
- NCT01921699
- Acronym / sponsor ID
- pending
- Keywords
- macrophages, adenocarcinoma, chemoresistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (estimated)
- First posted
- 13 Aug 2013 (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.
Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been postulated as being involved in the progression of cancer.
Based on our preliminary findings and on published data we hypothesized that macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells during chemotherapy.
The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of Pancreatic ductal adenocarcinoma (PDA).
methods:
- The human PDA cell line Panc1 will be grown in suitable conditions.
- Macrophages will be produced by incubating mononuclear cells from the blood of healthy donors in medium with M-CSF for 7 days.
- TAMs will be generated by culturing these macrophages with tumor-culture conditioning medium (TCCM) of PDA Cells for an additional 72 hours.
- Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to macrophages CM.
- Cell proliferation will be quantified by light microscopy and by an XTT Cell Proliferation Assay Kit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irrelevant | Other | Procedure: taking blood samples from healthy people |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy people
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking blood samples from healthy people | Procedure or surgery | irrelevant |
Primary outcome
proliferation and migration of PANC1 cell line in the tested groups.
Time frame: one day to get the blood samples, and a year after that to complete the basic research
the macrophages will be isolated from the blood we'll get from the healthy volunteers. the outcome measure is related to the basic research and not clinical so there's no symptom/outcome related to the participants.
1 secondary outcome
To determine whether direct cell-to-cell interaction or soluble factors participate in MIC.
Time frame: a year from obtaining the blood samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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?
A study testing taking blood samples from healthy people in people with the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy., run by Rambam Health Care Campus.
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: status not confirmed, as of the sponsor's last update on 13 Aug 2013. 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?
Results are not available in the source record.
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?
proliferation and migration of PANC1 cell line in the tested groups. (time frame: one day to get the blood samples, and a year after that to complete the basic research). 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 13 Aug 2013.