Prostate CancerFACSNCT00524823
Early Detection of Prostate Cancer by FACS
An observational study of Prostate Cancer and Hyperplasia, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Hyperplasia
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Nina Kucherski, MD contact
Yihia Johari, MD contact
Israel1 site, 1 recruiting
- Recruiting
Urology Department, Ziv Medical Center
Safed, 20100
Yihia Johari, MD
Yihia Johari, MD
About this study
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.
- Conditions
- Prostate Cancer, Hyperplasia
- Keywords
- Prostate Cancer, Hyperplasia - BPH, FACS, Prostate Cancer, Hyperplasia - BPH, Malignancy
- Medical subject headings
- Prostatic Neoplasms, Hyperplasia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Nina Kucherski, MD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524823
- Sponsor's protocol ID
- HP 7-251 S
- Acronym
- FACS
- Status last verified
- Aug 2007
- First submitted
- 3 Sep 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10332488Altman, 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Prostate Cancer by FACS
- ClinicalTrials.gov ID
- NCT00524823
- Acronym / sponsor ID
- FACS / HP 7-251 S
- Conditions
- Prostate Cancer, Hyperplasia
- Keywords
- Prostate Cancer, Hyperplasia - BPH, FACS, Prostate Cancer, Hyperplasia - BPH, Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2007
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2007.
- Background: PubMed 10332488Klein 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.
- BackgroundAltman, Roberta. The prostate Answer Book. Warner Books, lnc., 1993.
- BackgroundAmerican Cancer Society. National Cnference on Prostate Cancer. Philadelphia, Pennsylvania: September/October 1994.
- BackgroundRous, Stephen N., M.D.; The prostate Book. W.W. Norton & Co., 1992.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Kucherski, MD contact
Yihia Johari, MD contact
Nina Kucherski, MD principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Hyperplasia, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Kucherski, MD (050-8434041), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524823, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2007.