NCT00855998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 3, 2010

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

February 22, 2009

Last Update Submit

June 2, 2010

Conditions

Keywords

Thymidine Kinase 1BRCA1 and BRCA2 mutationshereditary breast/ovarian cancer

Study Arms (2)

1

With BRCA1 or BRCA2 mutations

2

Without BRCA1 or BRCA2 mutations

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant women;
  • women with generalized CMV and HZV infections;
  • women with severe B12 deficiency and megaloblastic anaemia;
  • women with severe rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Tamar Peretz, MD

CONTACT

Hadas Lemberg, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2009

First Posted

March 5, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

June 3, 2010

Record last verified: 2009-03

Locations