Breast CancerNCT00855998
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer
An observational study of Breast Cancer and Ovarian Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Mar 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women visiting the outpatient oncology clinic for genetic/familial high-risk assessments
Who may be able to join
- women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age;
- women from family with more than three breast cancer cases diagnosed before the age 50;
- women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer.
Who cannot join
- pregnant women;
- women with generalized CMV and HZV infections;
- women with severe B12 deficiency and megaloblastic anaemia;
- women with severe rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 6776095 ext. 00 972 2, arik@hadassah.org.il
Benjamin Nisman, PhD
About this study
This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.
Read the detailed description
Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity.
A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Thymidine Kinase 1, BRCA1 and BRCA2 mutations, hereditary breast/ovarian cancer
- Medical subject headings
- Breast Neoplasms, Ovarian 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 | With BRCA1 or BRCA2 mutations | |
| 2 | Without BRCA1 or BRCA2 mutations |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855998
- Sponsor's protocol ID
- 044608-HMO-CTIL
- Status last verified
- Mar 2009
- First submitted
- 22 Feb 2009
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nisman B, Kadouri L, Allweis T, Maly B, Hamburger T, Gronowitz S, Peretz T. Increased proliferative background in healthy women with BRCA1/2 haploinsufficiency is associated with high risk for breast cancer. Cancer Epidemiol Biomarkers Prev. 2013 Nov;22(11):2110-5. doi: 10.1158/1055-9965.EPI-13-0193. Epub 2013 Aug 21.
PubMed 23966579
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00855998
- Acronym / sponsor ID
- 044608-HMO-CTIL
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Thymidine Kinase 1, BRCA1 and BRCA2 mutations, hereditary breast/ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 5 Mar 2009 (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 compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.
Detailed description
Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity.
A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –With BRCA1 or BRCA2 mutations |
| 2 | – | –Without BRCA1 or BRCA2 mutations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women visiting the outpatient oncology clinic for genetic/familial high-risk assessments
Key inclusion criteria (3 listed)
- women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age;
- women from family with more than three breast cancer cases diagnosed before the age 50;
- women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer.
Key exclusion criteria (4 listed)
- pregnant women;
- women with generalized CMV and HZV infections;
- women with severe B12 deficiency and megaloblastic anaemia;
- women with severe rheumatoid arthritis.
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 3 Jun 2010.
- Derived from this study: PubMed 23966579Nisman B, Kadouri L, Allweis T, Maly B, Hamburger T, Gronowitz S, Peretz T. Increased proliferative background in healthy women with BRCA1/2 haploinsufficiency is associated with high risk for breast cancer. Cancer Epidemiol Biomarkers Prev. 2013 Nov;22(11):2110-5. doi: 10.1158/1055-9965.EPI-13-0193. Epub 2013 Aug 21.
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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.
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 and Ovarian 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 3 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 3 Jun 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. 00 972 2, tamary@hadassah.org.il), 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 NCT00855998, which also lists 1 linked publication.
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 3 Jun 2010.