NCT00851604

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 3, 2010

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

February 25, 2009

Last Update Submit

June 2, 2010

Conditions

Neuroendocrine Tumors

Keywords

ProGRPCgANSETUM2-PKNeuroendocrine Tumors

Study Arms (1)

1

Patients with malignant neuroendocrine tumors

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with neuroendocrine tumors

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women
  • Coexistence of another primary malignant tumor other then neuroendocrine tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Asher Salmon, M.D.

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asher Salmon, M.D., Ph.D.

CONTACT

6778199aysalmon@gmail.com

Hadas Lemberg, PhD

CONTACT

6777572lhadas@hadassah.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

January 1, 2011

Last Updated

June 3, 2010

Record last verified: 2010-05

Locations

IL(1)