Early Detection of Prostate Cancer by FACS | NCT00524823

Studies
Early Detection of Prostate Cancer by FACS

NCT00524823

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Sep 5, 2007Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Prostate Cancer
Hyperplasia

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 3, 2007

First Submission Date that Met QC Criteria

Sep 4, 2007

First Posted Date

Sep 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2007

Last Update Posted Date

Sep 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Nina Kucherski, MD	Contact	050-8434041
Yihia Johari, MD	Contact	050-8434094

Name	Affiliation	Role
Nina Kucherski, MD	Ziv Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Urology Department, Ziv Medical Center	Recruiting	Safed		20100	Israel

References Module

Citations

PubMed Identifier	Type	Citation
10332488	Background	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.
	Background	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.

ID	Term
D011471	Prostatic Neoplasms
D006965	Hyperplasia
D009369	Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male