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Tissue Study of Bv8/PK-2 Inhibition in Human Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656824
First Posted: August 3, 2012
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose
Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

Condition
Cancer

Study Type: Observational
Official Title: Study of Human Primary Cancer Tissue Implanted in Mice Lacking Bv8/PH-2 in Their Bone Marrow-derived Cells

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Tumor growth in xenograft model [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
cancer tissues

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:
1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with pancreatic cancer and are candidates for whipple's procedure
Criteria

Inclusion Criteria:

  • ages 18-85 years
  • Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy

Exclusion Criteria:

  • refuse to take part
  • preoperative chemotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656824


Contacts
Contact: Erez Hasnis, MD; PhD 972-50-2061911 e_hasnis@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Erez Hasnis, MD;PhD    972-50-2061911    e_hasnis@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Erez Hasnis, MD;PhD Rambam Health Care Campus
Principal Investigator: Erez Hasnis, MD; PhD. Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01656824     History of Changes
Other Study ID Numbers: Bv8/PK-2CTIL
First Submitted: August 1, 2012
First Posted: August 3, 2012
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Rambam Health Care Campus:
Bv8/PK-2
MDSC Myeloid Derived Suppressor Cells
BMDC Bone Marrow Derived Cells
Angiogenesis
Pancreatic Cancer