NCT01656824

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

August 1, 2012

Last Update Submit

November 20, 2013

Conditions

Cancer

Keywords

Bv8/PK-2MDSC Myeloid Derived Suppressor CellsBMDC Bone Marrow Derived CellsAngiogenesisPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor growth in xenograft model

    2 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with pancreatic cancer and are candidates for whipple's procedure

You may qualify if:

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

You may not qualify if:

  • refuse to take part
  • preoperative chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cancer tissues

MeSH Terms

Conditions

NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Erez Hasnis, MD;PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Erez Hasnis, MD; PhD.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Hasnis, MD; PhD

CONTACT

972-50-2061911e_hasnis@rambam.health.gov.il

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

IL(1)