NCT00524823

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

September 5, 2007

Status Verified

August 1, 2007

First QC Date

September 3, 2007

Last Update Submit

September 4, 2007

Conditions

Keywords

Prostate CancerHyperplasia - BPHFACSProstate Cancer, Hyperplasia - BPH, Malignancy

Study Arms (4)

1

10 diagnosed men in age 60 - 90 with Prostate Cancer

2

10 patients with benign growth

3

10 health volunteers

4

10 patients diagnosed with other cancer

Eligibility Criteria

Age60 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department, Ziv Medical Center

Safed, 20100, Israel

RECRUITING

Related Publications (4)

  • 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.

    PMID: 10332488BACKGROUND
  • Altman, Roberta. The prostate Answer Book. Warner Books, lnc., 1993.

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

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

    BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsHyperplasiaNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nina Kucherski, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Kucherski, MD

CONTACT

Yihia Johari, MD

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 5, 2007

Study Start

August 1, 2007

Last Updated

September 5, 2007

Record last verified: 2007-08

Locations