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Early Detection of Prostate Cancer by FACS (FACS)

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ClinicalTrials.gov Identifier: NCT00524823
Recruitment Status : Unknown
Verified August 2007 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2007
Last Update Posted : September 5, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Early detection of prostrate cancer and development of metastases. The research will attempt to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the CellScan instrument. The test is based on measurement of cellular changes in response to the specific prostate antigen, PSA.

Condition or disease Phase
Prostate Cancer Hyperplasia Phase 4

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Case: 1
10 diagnosed men in age 60 - 90 with Prostate Cancer
Case: 2
10 patients with benign growth
Control: 3
10 health volunteers
Control: 4
10 patients diagnosed with other cancer


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Experimental group : Males between the ages of 60-90 years, with medical diagnosis of prostate cancer according to both clinical and hematological examinations, before receiving any medical treatment.

Control Group 1: Males between the ages of 60-90 years, with diagnosed benign prostate hyperplasia -BPH.

Control Group 2: Males between the ages of 60-90 years, medically diagnosed as healthy.

Control Group 3: Males between the ages of 60-90 years, medically diagnosed with another form of cancer, not prostate.

Exclusion Criteria:

Experimental group: Other known cancer or systemic infection. Control Group 1: Other known cancer or systemic infection. Control Group 2:Past hematological disorders nor cancer growth history. other known systemic infection, nor urinary tract infection. Patients hospitalized for orthopedic injuries of any type who are otherwise free of urinary tract infections.

Control Group 3:Other known systemic infection, nor urinary tract infection.

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): NCT00524823


Contacts
Contact: Nina Kucherski, MD 050-8434041
Contact: Yihia Johari, MD 050-8434094

Locations
Israel
Urology Department, Ziv Medical Center Recruiting
Safed, Israel, 20100
Contact: Yihia Johari, MD         
Sub-Investigator: Yihia Johari, MD         
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Nina Kucherski, MD Ziv Medical Center
More Information

Publications:
Altman, Roberta. The prostate Answer Book. Warner Books, lnc., 1993.
American Cancer Society. National Cnference on Prostate Cancer. Philadelphia, Pennsylvania: September/October 1994.
Rous, Stephen N., M.D.; The prostate Book. W.W. Norton & Co., 1992.

ClinicalTrials.gov Identifier: NCT00524823     History of Changes
Other Study ID Numbers: HP 7-251 S
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: August 2007

Keywords provided by Ziv Hospital:
Prostate Cancer
Hyperplasia - BPH
FACS
Prostate Cancer, Hyperplasia - BPH, Malignancy

Additional relevant MeSH terms:
Prostatic Neoplasms
Hyperplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes