Evaluation of Thymidine Kinase Activity in the Serum of Patients With Solid Tumors

NCT ID: NCT01050413

Last Updated: 2010-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

Brief Summary

This study aimed to evaluate serum thymidine kinase 1 (TK1) activity as a marker for solid tumors and more specifically in: preoperative testing for prediction of disease recurrence and survival; follow-up after surgical removal of the original tumor for early detection of disease recurrence and in monitoring therapy as a surrogate marker of tumor response.

Detailed Description

Thymidine kinase 1 (TK1) is a metabolic enzyme catalyzing the ATP-dependent phosphorylation of thymidine to thymidine monophosphate followed by its utilization in DNA synthesis. It has been demonstrated that activity of TK1 in the serum of cancer patients corresponds to the amount of dividing tumor cells. Several clinical investigations clearly showed that abnormal TK1 levels indicate tumor growth. In breast cancer, serum TK1 was shown to predict increased risk of recurrence following surgery and may be a good marker for monitoring the response to therapy. The measurements of TK1 were useful as a prognostic and monitoring factor in patients with NSCLC. Unfortunately, all previously used assays measuring TK1 activity showed relatively low analytical sensitivity. Recently, the novel high sensitive non-radioactive TK1 assay (DiviTum) has been developed. With this assay tumour growth may be detected at an earlier stage of disease and smaller amounts of residual disease may be detected during and after therapy.

Conditions

Solid Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

colon cancer, prostate cancer, lung cancer, ovarian cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients with colon, breast, prostate and lung cancer before and during treatment

Exclusion Criteria

• pregnant women;
• patients with generalized CMV and HZV infections;
• patients with severe rheumatoid arthritis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Tamar Peretz, MD

Role: CONTACT

tamary@hadassah.org.il

6777825 ext. 00 972 2

Hadas Lemberg, PhD

Role: CONTACT

lhadas@hadassah.org.il

6777572 ext. 00 972 2

Facility Contacts

Arik Tzukert, DMD

Role: primary

arik@hadassah.org.il

6776095 ext. 00 972 2

Other Identifiers

044108-HMO-CTL

Identifier Type: -

Identifier Source: org_study_id