Malignant Breast Cancer, Benign Breast LesionsNCT00407706
Using Test of SCM for Detection Breast Cancer
An observational study of Malignant Breast Cancer, Benign Breast Lesions, run by Ziv Hospital at 1 site in Israel.
Trial summary
In our previous research, we have shown that women that have breast cancer have a population of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through physical change a short time after exposure in vitro to the same antigen. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Malignant Breast Cancer, Benign Breast Lesions
- What is being tested?
- blood test
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Dec 2010
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women carrying benign breast lesions will be further divided and analyzed according to the Fitzgibbon's risk categories for invasive cancer risk (4). The Fitzgibbon's categories are:
- No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features,
- slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis,
- moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and
- markedly increased risk group (8.0-10.0 times) which includes ductal and lobular carcinomas In Situ Following the blood collection, detailed relevant clinical information of the patient will be registered in a case record form.
- The data will include: age, country of birth, last menstrual period, lactation, number of children, age at first full-term pregnancy, age at onset of menopause, family history, medication, mammography findings, FNA results, tumor size, histological findings, biopsies, disease staging, and other relevant clinical information.
Who cannot join
- pregnancy,
- experiencing menstruation, or
- under hormonal or drug treatment.
Trial locations and contacts
1 site in 1 country.
Amram Hadari, MD contact
Israel1 site, 1 recruiting
- Recruiting
Surgery Department
Safed, 13110
Amram Hadari, MD, + 972 4 6828923
Tali Keren, MA, + 972 4 682 8828
About this study
Official title: Breast Cancer- Early Detection of Cancer Disease and Pre-Cancer Disease, and in Women That Are at High Risk for Developing Breast Cancer by Identifying Lymphocytes Previously Exposed to Specific Cancer Antigen.
In our previous research, we have shown that women that have breast cancer have a population of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through physical change a short time after exposure in vitro to the same antigen. This change can be measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate) labeled cells. Further test that we performed showed that those differences are also shown in a benign situation that known as indicator for a high risk for developing breast cancer within 10-15 years. The incidence of the expression of these lymphocytes correlates with the histopathological picture as it is related in high risk for the developing the disease.
In this work we will expand the scope of the procedure to early detection of the cancerous process in breast lesions by Fitzgibbon's risk categories for the development invasive carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for breast cancer. This study is a continuation of our published work in the "The Breast "
- Being tested
- blood test
- Keywords
- Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Malignant Breast Cancer, Benign Breast LesionsStudies 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
- Other
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Amram Hadari, MD, Principal investigator, Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407706
- Sponsor's protocol ID
- HP 6-218 S
- Status last verified
- Dec 2006
- First submitted
- 4 Dec 2006
- Last updated
- 5 Dec 2006
- Results posted
- No
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 10332488Klein O, Linn S, Hadari A, Davidson C, Eitan A, Zidan J, Kook AI. An approach for high sensitivity detection of breast cancer by analysis of changes in structure of the cytoplasmic matrix of lymphocytes specifically induced by a specific breast tumour antigen (MUC-l/SEC). Breast. 2002 Apr;11(2):137-43. doi: 10.1054/brst.2001.0315.
PubMed 14965660Fitzgibbons PL, Henson DE, Hutter RV. Benign breast changes and the risk for subsequent breast cancer: an update of the 1985 consensus statement. Cancer Committee of the College of American Pathologists. Arch Pathol Lab Med. 1998 Dec;122(12):1053-5.
PubMed 9870852Smorodinsky N, Weiss M, Hartmann ML, Baruch A, Harness E, Yaakobovitz M, Keydar I, Wreschner DH. Detection of a secreted MUC1/SEC protein by MUC1 isoform specific monoclonal antibodies. Biochem Biophys Res Commun. 1996 Nov 1;228(1):115-21. doi: 10.1006/bbrc.1996.1625.
PubMed 8912645Karanikas V, Hwang LA, Pearson J, Ong CS, Apostolopoulos V, Vaughan H, Xing PX, Jamieson G, Pietersz G, Tait B, Broadbent R, Thynne G, McKenzie IF. Antibody and T cell responses of patients with adenocarcinoma immunized with mannan-MUC1 fusion protein. J Clin Invest. 1997 Dec 1;100(11):2783-92. doi: 10.1172/JCI119825.
PubMed 9389743Hiltbold EM, Ciborowski P, Finn OJ. Naturally processed class II epitope from the tumor antigen MUC1 primes human CD4+ T cells. Cancer Res. 1998 Nov 15;58(22):5066-70.
PubMed 9823312Kelly JM, Darcy PK, Markby JL, Godfrey DI, Takeda K, Yagita H, Smyth MJ. Induction of tumor-specific T cell memory by NK cell-mediated tumor rejection. Nat Immunol. 2002 Jan;3(1):83-90. doi: 10.1038/ni746. Epub 2001 Dec 17.
PubMed 11743585Klein O, Linn S, Davidson C, Hadary A, Shukha A, Zidan J, Eitan A, Kook AI. Early detection of malignant process in benign lesions of breast tumor by measurements of changes in structuredness of cytoplasmic matrix in circulating lymphocytes (SCM test) reinduced in vitro by specific tumor antigen. Breast. 2002 Dec;11(6):478-83. doi: 10.1054/brst.2002.0477.
PubMed 14965713
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer- Early Detection of Cancer Disease and Pre-Cancer Disease, and in Women That Are at High Risk for Developing Breast Cancer by Identifying Lymphocytes Previously Exposed to Specific Cancer Antigen.
- ClinicalTrials.gov ID
- NCT00407706
- Acronym / sponsor ID
- HP 6-218 S
- Keywords
- Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Dec 2006
- Study completion
- Dec 2010
- First posted
- 5 Dec 2006 (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.
In our previous research, we have shown that women that have breast cancer have a population of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through physical change a short time after exposure in vitro to the same antigen. This change can be measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate) labeled cells. Further test that we performed showed that those differences are also shown in a benign situation that known as indicator for a high risk for developing breast cancer within 10-15 years. The incidence of the expression of these lymphocytes correlates with the histopathological picture as it is related in high risk for the developing the disease.
In this work we will expand the scope of the procedure to early detection of the cancerous process in breast lesions by Fitzgibbon's risk categories for the development invasive carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for breast cancer. This study is a continuation of our published work in the "The Breast "
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women carrying benign breast lesions will be further divided and analyzed according to the Fitzgibbon's risk categories for invasive cancer risk (4). The Fitzgibbon's categories are:
- No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features,
- slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis,
- moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and
- markedly increased risk group (8.0-10.0 times) which includes ductal and lobular carcinomas In Situ Following the blood collection, detailed relevant clinical information of the patient will be registered in a case record form.
Key exclusion criteria (3 listed)
- pregnancy,
- experiencing menstruation, or
- under hormonal or drug treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood test | Procedure or surgery | – |
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 Dec 2006.
- 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.
- Background: PubMed 14965660Klein O, Linn S, Hadari A, Davidson C, Eitan A, Zidan J, Kook AI. An approach for high sensitivity detection of breast cancer by analysis of changes in structure of the cytoplasmic matrix of lymphocytes specifically induced by a specific breast tumour antigen (MUC-l/SEC). Breast. 2002 Apr;11(2):137-43. doi: 10.1054/brst.2001.0315.
- Background: PubMed 9870852Fitzgibbons PL, Henson DE, Hutter RV. Benign breast changes and the risk for subsequent breast cancer: an update of the 1985 consensus statement. Cancer Committee of the College of American Pathologists. Arch Pathol Lab Med. 1998 Dec;122(12):1053-5.
- Background: PubMed 8912645Smorodinsky N, Weiss M, Hartmann ML, Baruch A, Harness E, Yaakobovitz M, Keydar I, Wreschner DH. Detection of a secreted MUC1/SEC protein by MUC1 isoform specific monoclonal antibodies. Biochem Biophys Res Commun. 1996 Nov 1;228(1):115-21. doi: 10.1006/bbrc.1996.1625.
- Background: PubMed 9389743Karanikas V, Hwang LA, Pearson J, Ong CS, Apostolopoulos V, Vaughan H, Xing PX, Jamieson G, Pietersz G, Tait B, Broadbent R, Thynne G, McKenzie IF. Antibody and T cell responses of patients with adenocarcinoma immunized with mannan-MUC1 fusion protein. J Clin Invest. 1997 Dec 1;100(11):2783-92. doi: 10.1172/JCI119825.
- Background: PubMed 9823312Hiltbold EM, Ciborowski P, Finn OJ. Naturally processed class II epitope from the tumor antigen MUC1 primes human CD4+ T cells. Cancer Res. 1998 Nov 15;58(22):5066-70.
- Background: PubMed 11743585Kelly JM, Darcy PK, Markby JL, Godfrey DI, Takeda K, Yagita H, Smyth MJ. Induction of tumor-specific T cell memory by NK cell-mediated tumor rejection. Nat Immunol. 2002 Jan;3(1):83-90. doi: 10.1038/ni746. Epub 2001 Dec 17.
- Results publication: PubMed 14965713Klein O, Linn S, Davidson C, Hadary A, Shukha A, Zidan J, Eitan A, Kook AI. Early detection of malignant process in benign lesions of breast tumor by measurements of changes in structuredness of cytoplasmic matrix in circulating lymphocytes (SCM test) reinduced in vitro by specific tumor antigen. Breast. 2002 Dec;11(6):478-83. doi: 10.1054/brst.2002.0477.
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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.
Amram Hadari, MD contact
Amram Hadari, MD principal investigator
Surgery Department
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 Malignant Breast Cancer, Benign Breast Lesions, 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 6 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 Dec 2006. 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 Amram Hadari, MD (+ 972 6828923), 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 NCT00407706, which also lists 8 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 Dec 2006.