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ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Serological Markers ProGRP, CgA, NSE and TUM2-PK in Patients With Malignant Neuroendocrine Tumors
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Patients with malignant neuroendocrine tumors


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Serum and plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients with neuroendocrine tumors
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00851604


Contacts
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Contact: Asher Salmon, M.D., Ph.D. 6778199 ext 00 972 2 aysalmon@gmail.com
Contact: Hadas Lemberg, PhD 6777572 ext 00 972 2 lhadas@hadassah.org.il

Locations
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Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    6776095 ext 00 972 2    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    6777572 ext 00 972 2    lhadas@hadassah.org.il   
Sub-Investigator: Benjamin Nisman, PhD         
Sub-Investigator: Tamar Peretz, M.D., PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Asher Salmon, M.D. Hadassah Medical Organization
More Information
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Responsible Party: Asher Salmon, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00851604    
Other Study ID Numbers: 052508-HMO-CTIL
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: May 2010
Keywords provided by Hadassah Medical Organization:
ProGRP
CgA
NSE
TUM2-PK
Neuroendocrine Tumors
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue