Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas (LoG-Glio)

May 10, 2023 updated by: Jan Coburger, University of Ulm

Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas: The LOG-Glio-Project

The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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

Study Locations

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

Sampling Method

Probability Sample

Study Population

All adult patients with radiological suspected diagnosis of a low grade glioma

Description

Inclusion Criteria:

  • Patients with radiological suspected diagnosis of a low grade glioma
  • Age ≥ 18 years. There is no upper age limit.

Exclusion Criteria:

  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  • No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
  • No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 5yrs
5yrs
Overall survival (OS)
Time Frame: 15yrs
15yrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of tumor resection
Time Frame: 3yrs
calculated based on volumetric assessement of tumor in cm³ and residual tumor in pre and postoperative MRI
3yrs
Quality of life (QoL) assessed by the EORTC QLQ C-30/BN-20. (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30
Time Frame: 5yrs
5yrs

Collaborators and Investigators

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

Sponsor

University of Ulm

Collaborators

Charite University, Berlin, Germany

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 (Actual)

November 15, 2015

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 1, 2036

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LoG-Glio

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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