Breast CancerNCT01043055
Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40
An observational study of Breast Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jan 2011
- 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 40 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients over age 40 before treatment. Healthy women recruited in Check Up institute from asymptomatic women over age 40, referred to screening mammography and received the negative result of mammography.
Who may be able to join
- Inclusion Criteria for Breast Cancer Patients for Experimental Group:
- Patient is over the age of 40.
- Patient is willing to participate as evidenced by signing the written informed consent form.
- Patient referred to the Department of Oncology/ Surgery for operative treatment of breast cancer with previously detected disease. Positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast CT, biopsy.
- Non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy).
- Patient without other cancer locations
Show all 12Show fewer
- Inclusion Criteria for Presumably Healthy Subjects for Control Group:
- Subjects over the age of 40.
- Subjects who are willing to participate as evidenced by signing the written informed consent form.
- Subjects who are presumably healthy and without breast pathologies' symptoms and family history of breast cancer, i.e., breast disease (except history of functional breast problems, e.g., mastitis within lactation period) has been ruled out based on physician anamnesis
- Subjects with negative results of screening mammography.
- Subjects without taking of any hormonal medicines
Who cannot join
- Subjects with any known cancer in other internal organs or systems.
- Subjects with high fever presentation (more than 38.5).
- Subjects with known breast disease undergoing treatment for the disease.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, Jerusalem, 91120
Arik Tzukert, DmD, 6776095 ext. 009722, arik@hadassah.org.il
Hadas Lemberg, PhD, 6777572 ext. 009722, Lhadas@hadassah.org.il
About this study
Official title: Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40
This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.
Read the detailed description
Breast cancer diagnosis is a rapidly expanding research field, whose early-stage detection may reduce the burden of the disease and permit more effective treatment. It is well documented that tumor growth requires specific conditions for its development from the occurrence of a mutation to a clinically detectable cancer. It has been shown that living peripheral blood mononuclear cells (PBMC) have different ability of cytosolic enzymes (esterases) to convert hydrophobic substrate fluorescein diacetate (FDA) into hydrophilic fluorescent fluorescein. It depends on PBMC cycle stage, size, surface state, physiological states, such as activation and apoptosis.
The important step of breast cancer genesis is the early change of functional activity of cytosolic enzymes (esterases) in peripheral blood mononuclear cells. Such transformations in PBMC may be detected accurately by an existing device Flowcytometer (FACS™ MultiSET™ System, company "Becton Dickinson" GmbH, USA), where measurements of fluorescence polarization and enzymatic hydrolysis of FDA substrate are recorded. A conclusion about presentation of breast cancer among examined women is achieved by "CDT" (cancer detection technology) software, which analyzes mathematically the results of fluorescence polarization and enzymatic hydrolysis.
Moreover, the combined biochemical model together with additional prognostic parameters (such as age, ethnic group, gynecological and obstetric anamnesis) increases the validity (accuracy, sensitivity and specificity) of the diagnostic conclusion.
Diagnostic Solution of the CDT:
- Mathematical processing of specific blood analysis in device Flowcytometer.
- Mathematical evaluation of specific prognostic parameters
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Screening
- Medical subject headings
- Breast 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 |
|---|---|---|
| Breast Cancer Patients | Not described | |
| Healthy Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40
Measured: one year
Secondary outcomes (2)
To correlate the technology with standard test - screening mammography and biopsy
Measured: two years
To validate and compare the diagnostic ability of the CDT for detection of breast cancer
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Tamar Peretz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043055
- Sponsor's protocol ID
- 044809-HMO-CTIL
- Status last verified
- Oct 2009
- First submitted
- 5 Jan 2010
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40
- ClinicalTrials.gov ID
- NCT01043055
- Acronym / sponsor ID
- 044809-HMO-CTIL
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 6 Jan 2010 (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.
This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.
Detailed description
Breast cancer diagnosis is a rapidly expanding research field, whose early-stage detection may reduce the burden of the disease and permit more effective treatment. It is well documented that tumor growth requires specific conditions for its development from the occurrence of a mutation to a clinically detectable cancer. It has been shown that living peripheral blood mononuclear cells (PBMC) have different ability of cytosolic enzymes (esterases) to convert hydrophobic substrate fluorescein diacetate (FDA) into hydrophilic fluorescent fluorescein. It depends on PBMC cycle stage, size, surface state, physiological states, such as activation and apoptosis.
The important step of breast cancer genesis is the early change of functional activity of cytosolic enzymes (esterases) in peripheral blood mononuclear cells. Such transformations in PBMC may be detected accurately by an existing device Flowcytometer (FACS™ MultiSET™ System, company "Becton Dickinson" GmbH, USA), where measurements of fluorescence polarization and enzymatic hydrolysis of FDA substrate are recorded. A conclusion about presentation of breast cancer among examined women is achieved by "CDT" (cancer detection technology) software, which analyzes mathematically the results of fluorescence polarization and enzymatic hydrolysis.
Moreover, the combined biochemical model together with additional prognostic parameters (such as age, ethnic group, gynecological and obstetric anamnesis) increases the validity (accuracy, sensitivity and specificity) of the diagnostic conclusion.
Diagnostic Solution of the CDT:
- Mathematical processing of specific blood analysis in device Flowcytometer.
- Mathematical evaluation of specific prognostic parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | – |
| Healthy Control Group | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients over age 40 before treatment. Healthy women recruited in Check Up institute from asymptomatic women over age 40, referred to screening mammography and received the negative result of mammography.
Key inclusion criteria (12 listed)
- Patient is over the age of 40.
- Patient is willing to participate as evidenced by signing the written informed consent form.
- Patient referred to the Department of Oncology/ Surgery for operative treatment of breast cancer with previously detected disease. Positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast CT, biopsy.
- Non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy).
- Patient without other cancer locations
Key exclusion criteria (4 listed)
- Subjects with any known cancer in other internal organs or systems.
- Subjects with high fever presentation (more than 38.5).
- Subjects with known breast disease undergoing treatment for the disease.
- Pregnant or lactating women
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
To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40
Time frame: one year
2 secondary outcomes
To correlate the technology with standard test - screening mammography and biopsy
Time frame: two years
To validate and compare the diagnostic ability of the CDT for detection of breast cancer
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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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.
Tamar Peretz, MD principal investigator
Hadassah Medical Organization
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 Breast Cancer, run by Hadassah Medical Organization 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 12 inclusion and 4 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 6 Jan 2010. 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 Tamar Peretz, MD (6777825 ext. 009722, tamary@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2010.