Full Text View
Tabular View
No Study Results Posted
Related Studies
ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, February 2009
First Received: February 25, 2009   No Changes Posted
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00851604
  Purpose

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
Neuroendocrine Tumors

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Evaluation of Serological Markers ProGRP, CgA, NSE and TUM2-PK in Patients With Malignant Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Serum and plasma


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851604

Contacts
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
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Asher Salmon, M.D. Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization ( Asher Salmon )
Study ID Numbers: 052508-HMO-CTIL
Study First Received: February 25, 2009
Last Updated: February 25, 2009
ClinicalTrials.gov Identifier: NCT00851604     History of Changes
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
ProGRP
CgA
NSE
TUM2-PK
Neuroendocrine Tumors

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Calcium Carbonate
Neuroendocrine Tumors

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on September 10, 2009