microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer

November 15, 2016 updated by: Natalia Goldberg, Assuta Medical Center
In our study, the investigators want to find correlation between circulating miRNAs associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68Ga-PSMA ligand PET (positron emission computed) imaging.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with high PSA levels

Description

Inclusion Criteria:

  • Proven Adeno-carcinoma
  • Underwent prostatectomy and still present high PSA levels
  • Refered to PSMA exam.

Exclusion Criteria:

  • Below 18 years old
  • HIV/HBV (hepatitis B virus)/HCV (hepatitis C virus) positive
  • Additional malignancy during the past five years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High PSA (prostate-specific antigen) levels
Biological: High PSA levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis size and location
Time Frame: 18 months
Location of metastasis by a report analyzing the pathological examination (PET-MR output).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MicroRNA profile by using Nano-string technology validated by real time PCR
Time Frame: 24 months
Validation of MicroRNA pattern by using real time PCR
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Medical Center

Investigators

  • Principal Investigator: Natalia Goldberg, MD, Assuta Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0093-16-ASMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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