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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01921699
Other study ID # pending
Secondary ID pending
Status Not yet recruiting
Phase N/A
First received August 5, 2013
Last updated August 9, 2013
Start date August 2013

Study information

Verified date August 2013
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy people

Exclusion Criteria:

- refusal to participate

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • Pancreatic Neoplasms
  • the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.

Intervention

Procedure:
taking blood samples from healthy people


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one day to get the blood samples, and a year after that to complete the basic research No
Secondary To determine whether direct cell-to-cell interaction or soluble factors participate in MIC. a year from obtaining the blood samples No