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Isolation and Characterization of Cancer Stem Cells Using iFP Technique

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 July 2012 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641003
First Posted: July 16, 2012
Last Update Posted: July 16, 2012
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
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01641003     History of Changes
Other Study ID Numbers: cancer stem cells.ctil
First Submitted: June 26, 2012
First Posted: July 16, 2012
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Rambam Health Care Campus:
cancer stem cells

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