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Macrophages Effect on Chemoresistance

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ClinicalTrials.gov Identifier: NCT01921699
Recruitment Status : Unknown
Verified August 2013 by SHOROOK NA'ARA MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
SHOROOK NA'ARA MD, Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE August 5, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
To determine whether direct cell-to-cell interaction or soluble factors participate in MIC. [ Time Frame: a year from obtaining the blood samples ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Macrophages Effect on Chemoresistance
Official Title  ICMJE Impact of Macrophages on De-Novo Chemoresistance of Adenocarcinoma Cells
Brief 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.

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:

  1. The human PDA cell line Panc1 will be grown in suitable conditions.
  2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy donors in medium with M-CSF for 7 days.
  3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning medium (TCCM) of PDA Cells for an additional 72 hours.
  4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to macrophages CM.
  5. Cell proliferation will be quantified by light microscopy and by an XTT Cell Proliferation Assay Kit.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.
Intervention  ICMJE Procedure: taking blood samples from healthy people
Study Arms  ICMJE irrelevant
Intervention: Procedure: taking blood samples from healthy people
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 9, 2013)
2
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy people

Exclusion Criteria:

  • refusal to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921699
Other Study ID Numbers  ICMJE pending
pending ( Other Identifier: Rambam medical health campus )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SHOROOK NA'ARA MD, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rambam Health Care Campus
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP