Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas (MAGynMA)

January 12, 2021 updated by: University Women's Hospital Tübingen
The aim of the planned research project is to find out the clinical significance of molecular genetic analyzes in gynecological malignomas. In particular, it will be investigated how the knowledge of a molecular-genetic finding affects the therapeutic decision of the physician. Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs, DTCs and cfDNA.

Study Overview

Status

Unknown

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 Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Women's Hospital

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

Female

Sampling Method

Non-Probability Sample

Study Population

All patients with a gynecological malignancy, in whom a genetic testing of tumor tissue (somatic mutation) and blood cells (germ line mutation) has already taken place.

Description

Inclusion Criteria:

  • Patients with a solid tumor disease
  • The presence of a molecular genetic diagnosis of the tumor tissue from practice for human genetics
  • Age > 18 years
  • informed consent

Exclusion Criteria:

  • life expectancy <12 months or worse general condition (Karnofsky <70)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of molecular genetic findings to the therapy decision
Time Frame: 3years
It will be analyzed if the physicians selection of a therapy is influenced by a present molecular genetic finding. Therapy recommondation based on molecular genetic analysis will be compared with the acutal therapy decision.
3years

Collaborators and Investigators

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

Sponsor

University Women's Hospital Tübingen

Investigators

  • Principal Investigator: Andreas D Hartkopf, Prof, Department of Women's Health

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)

May 29, 2017

Primary Completion (Actual)

May 29, 2020

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MAGynMA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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