Neuroendocrine TumorsNCT00851604
ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with neuroendocrine tumors
Who may be able to join
- 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.
Who cannot join
- Pregnant women
- Coexistence of another primary malignant tumor other then neuroendocrine tumors
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 6776095 ext. 00 972 2, arik@hadassah.org.il
Hadas Lemberg, PhD, 6777572 ext. 00 972 2, lhadas@hadassah.org.il
About this study
Official title: Evaluation of Serological Markers ProGRP, CgA, NSE and TUM2-PK in Patients With Malignant Neuroendocrine Tumors
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.
Read the 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.
- Conditions
- Neuroendocrine Tumors
- Keywords
- ProGRP, CgA, NSE, TUM2-PK, Neuroendocrine Tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with malignant neuroendocrine tumors |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Asher Salmon, M.D., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851604
- Sponsor's protocol ID
- 052508-HMO-CTIL
- Status last verified
- May 2010
- First submitted
- 25 Feb 2009
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serological Markers ProGRP, CgA, NSE and TUM2-PK in Patients With Malignant Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00851604
- Acronym / sponsor ID
- 052508-HMO-CTIL
- Conditions
- Neuroendocrine Tumors
- Keywords
- ProGRP, CgA, NSE, TUM2-PK, Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with malignant neuroendocrine tumors |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with neuroendocrine tumors
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women
- Coexistence of another primary malignant tumor other then neuroendocrine tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Salmon, M.D. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asher Salmon, M.D., Ph.D. (6778199 ext. 00 972 2, aysalmon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.