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
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Condition or disease |
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Neuroendocrine Tumors |
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 |
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 |

Group/Cohort |
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1
Patients with malignant neuroendocrine tumors
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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 |
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

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
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 |
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 |
Principal Investigator: | Asher Salmon, M.D. | Hadassah Medical Organization |
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 |
ProGRP CgA NSE TUM2-PK Neuroendocrine Tumors |
Neuroendocrine Tumors Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue |