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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050413
Recruitment Status : Unknown
Verified December 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : June 3, 2010
Information provided by:
Hadassah Medical Organization

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.

Condition or disease
Solid Tumors

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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Serum Thymidine Kinase Activity in Diagnosis,Prognosis and Monitoring of Treatment in Patients With Solid Tumors
Study Start Date : February 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

colon cancer, prostate cancer, lung cancer, ovarian cancer

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients from oncology department and patients visiting outpatient, daycare oncology clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050413

Contact: Tamar Peretz, MD 6777825 ext 00 972 2
Contact: Hadas Lemberg, PhD 6777572 ext 00 972 2

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    6776095 ext 00 972 2   
Sub-Investigator: Benjamin Nisman, PhD         
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Prof. Tamar Peretz, Head of Oncology Department, Hadassah Medical Organization Identifier: NCT01050413     History of Changes
Other Study ID Numbers: 044108-HMO-CTL
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: December 2009

Keywords provided by Hadassah Medical Organization:
Thymidine Kinase 1 activity