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ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine 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: NCT00851604
Recruitment Status : Unknown
Verified May 2010 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : February 26, 2009
Last Update Posted : June 3, 2010
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date February 25, 2009
First Posted Date February 26, 2009
Last Update Posted Date June 3, 2010
Study Start Date March 2009
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors
Official Title Evaluation of Serological Markers ProGRP, CgA, NSE and TUM2-PK in Patients With Malignant Neuroendocrine Tumors
Brief Summary The purpose of this study is to determine whether monitoring of levels of Serological Markers ProGRP, CgA, NSE and Pyruvate Kinase M2 are effective in the Evaluation of Diagnosis, Monitoring Therapeutic Effects and Predicting response to somatostatin analogues in Patients with Malignant Neuroendocrine Tumors.
Detailed Description

Assessment of the anatomical spread and disease progression in neuroendocrine tumor patients has become an essential part of disease management, but sometimes in many patients difficult to be measured. Therefore, the evaluation of serum markers could represent a useful tool for monitoring the course of the disease and the response of patients to therapy or palliative treatment.Clinical data considers CgA and NSE as available today blood biomarkers for neuroendocrine tumors.Until now the usefulness of serum ProGRP as a clinical tumor marker has been evaluated mainly in Small Cell Lung Carcinoma, while its role in the management of NE tumors has not been elucidated.Available in the literature limited data suggests that ProGRP may be a potential tumor marker in NE tumors.

Pyruvate kinase type M2 is the key glycolytic regulator in tumor cells.It catalyzes the dephosphorylation of phosphoenolpyruvate to pyruvate with ATP production.The dimeric form of this enzyme (TUM2-PK) has been detected in the blood of patients with different cancers.High TUM2-PK expression was suggested to be an important element of tumor cell metabolism adaptation to an inadequate oxygen and nutrient supply.Recently, it has been shown that somatostatin and its structural analogues pass through cell membrane and actively bind to cytosolic TUM2-PK. In response to this binding TUM2-PK translocates into the nucleus and induce programmed cell death. It is suggested that TUM2-PK enzyme may contribute significantly to response of neuroendocrine tumors to somatostatin analogues.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Serum and plasma
Sampling Method Non-Probability Sample
Study Population The patients with neuroendocrine tumors
Condition Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts 1
Patients with malignant neuroendocrine tumors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February¬†25,¬†2009)
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2011
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The patients at diagnosis of neuroendocrine tumors before therapy will be approached to participate in the study.
  • Older then 18 years old
  • Patients who agree to participate will receive a detailed explanation and sign an informed consent form.

Exclusion Criteria:

  • Pregnant women
  • Coexistence of another primary malignant tumor other then neuroendocrine tumors
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
Administrative Information
NCT Number NCT00851604
Other Study ID Numbers 052508-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Asher Salmon, Hadassah Medical Organization
Study Sponsor Hadassah Medical Organization
Collaborators Not Provided
Principal Investigator: Asher Salmon, M.D. Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date May 2010