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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01050413
First received: January 5, 2010
Last updated: June 2, 2010
Last verified: December 2009
  Purpose

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
Solid Tumors

Study Type: Observational
Study Design: 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

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: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
colon cancer, prostate cancer, lung cancer, ovarian cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients from oncology department and patients visiting outpatient, daycare oncology clinic

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
  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: NCT01050413

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
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

Responsible Party: Prof. Tamar Peretz, Head of Oncology Department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01050413     History of Changes
Other Study ID Numbers: 044108-HMO-CTL
Study First Received: January 5, 2010
Last Updated: June 2, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Thymidine Kinase 1 activity
diagnosis
prognosis
follow-up

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014