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

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ClinicalTrials.gov Identifier: NCT03194347
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief Summary:
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.

Condition or disease Intervention/treatment
Gynecologic Cancer Diagnostic Test: molecular genetic analyses

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : May 31, 2021

Intervention Details:
  • Diagnostic Test: molecular genetic analyses
    molecular genetic analyses


Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   gynecological tumors
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194347


Contacts
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Contact: Andreas D Hartkopf, Prof 0049 7071 29 86299 andreas.hartkopf@med.uni-tuebingen.de

Locations
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Germany
University Women's Hospital Recruiting
Tübingen, Germany, 72076
Contact: Andreas D Hartkopf, Prof    0049 7071 29 86299    andreas.hartkopf@med.uni-tuebingen.de   
Sponsors and Collaborators
University Women's Hospital Tübingen
Investigators
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Principal Investigator: Andreas D Hartkopf, Prof Department of Women's Health

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Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT03194347     History of Changes
Other Study ID Numbers: MAGynMA
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No