Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00855998
First received: February 22, 2009
Last updated: June 2, 2010
Last verified: March 2009
  Purpose

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.


Condition
Breast Cancer
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
With BRCA1 or BRCA2 mutations
2
Without BRCA1 or BRCA2 mutations

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women visiting the outpatient oncology clinic for genetic/familial high-risk assessments

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855998

Contacts
Contact: Tamar Peretz, MD 6777825 ext 00 972 2 tamary@hadassah.org.il
Contact: Hadas Lemberg, PhD 6777572 ext 00 972 2 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    6776095 ext 00 972 2    arik@hadassah.org.il   
Sub-Investigator: Benjamin Nisman, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Tamar Peretz, Head of Oncology Department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00855998     History of Changes
Other Study ID Numbers: 044608-HMO-CTIL
Study First Received: February 22, 2009
Last Updated: June 2, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Thymidine Kinase 1
BRCA1 and BRCA2 mutations
hereditary breast/ovarian cancer

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 28, 2014