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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00524823
Other study ID # HP 7-251 S
Secondary ID
Status Recruiting
Phase Phase 4
First received September 3, 2007
Last updated September 4, 2007
Start date August 2007

Study information

Verified date August 2007
Source Ziv Hospital
Contact Nina Kucherski, MD
Phone 050-8434041
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 90 Years
Eligibility 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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Urology Department, Ziv Medical Center Safed

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Altman, Roberta. The prostate Answer Book. Warner Books, lnc., 1993.

American Cancer Society. National Cnference on Prostate Cancer. Philadelphia, Pennsylvania: September/October 1994.

Klein O, Lin S, Embon O, Sazbon A, Zidan J, Kook AI. An approach for high sensitivity detection of prostate cancer by analysis of changes in structuredness of the cytoplasmic matrix of lymphocytes specifically induced by PSA-ACT. J Urol. 1999 Jun;161(6):1994-6. — View Citation

Rous, Stephen N., M.D.; The prostate Book. W.W. Norton & Co., 1992.

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