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Isolation and Characterization of Cancer Stem Cells Using iFP Technique

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01641003
First received: June 26, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose
  1. to evaluate insoluble fibrinogen particles (iFP), as a tool for harvesting, growing and transferring attachment-dependent cancer stem cells and comparing it to the standard method ( coated plate) .
  2. to evaluate whether using iFP for growing CSC can yield better results of isolating and enriching CSCs from fresh tumors than other conventional methods

Condition
Malignant Neoplasm of Breast
Glioma
Pancreatic Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Isolation and Characterization of Cancer Stem Cells Using iFP Technique

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Cancer stem cells percentage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluation of CSCs and non-CSCs population by using several surface markers. For glioma and pancreas, CSC are defined as CD133 positive. For breast carcinoma CSCs are identified as CD44+/CD24-/Low. Percentage of CSCs will be measured for comparing the yield of the methods using iFP and the standard method.


Biospecimen Retention:   Samples Without DNA

Samples of fresh tumors taken after surgery without compromising final histology diagnosis. These specimens will be used to isolate and grow cancer stem cells.


Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fresh tumor specimen
Fresh tumor specimen taken immediately after surgery of patients diagnosed with pancreatic cancer, GBM and Breast cancer. These specimens will be taken immediately to the lab isolate and grow CSC using the described methods. No specific intervention done regarding the patients- the samples taken will be processed in the lab.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients newly diagnosed with GBM, Pancreas or Breast cancer who are planed to undergo surgery.

Criteria

Inclusion Criteria:

  1. Above 18 years old.
  2. Signed ICF.
  3. Expected to under go cancer removing surgery in Rambam MC.
  4. A sample of the tumor can be brought to the lab within 30 of its removal.
  5. Enough histological material to perform a good histological evaluation.

Exclusion Criteria:

  1. Patient not interested to participate in clinical trial.
  2. PI decision.
  3. Chemotherapy or radiotherapy treatment prior to surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641003

Contacts
Contact: FADI - MIZYED, Dr. +972-4-8543162 f_atrash@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: FADI - MIZYED, Dr.    +972-4-8543162      
Principal Investigator: FADI - MIZYED, MD.         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: FADI - MIZYED, Dr. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01641003     History of Changes
Other Study ID Numbers: cancer stem cells.ctil
Study First Received: June 26, 2012
Last Updated: July 11, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
cancer stem cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Pancreatic Neoplasms
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014