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Trial Title:
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer
NCT ID:
NCT00855998
Condition:
Breast Cancer
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Thymidine Kinase 1
BRCA1 and BRCA2 mutations
hereditary breast/ovarian cancer
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
women visiting the outpatient oncology clinic for genetic/familial high-risk assessments
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:•
- pregnant women;
- women with generalized CMV and HZV infections;
- women with severe B12 deficiency and megaloblastic anaemia;
- women with severe rheumatoid arthritis.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hadassah Medical Organization
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Arik Tzukert, DMD
Phone:
6776095
Phone ext:
00 972 2
Email:
arik@hadassah.org.il
Investigator:
Last name:
Benjamin Nisman, PhD
Email:
Sub-Investigator
Start date:
March 2009
Completion date:
March 2011
Lead sponsor:
Agency:
Hadassah Medical Organization
Agency class:
Other
Source:
Hadassah Medical Organization
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00855998