Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas

NCT03194347 | Completed

• 1 other identifier: MAGynMA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Influence of molecular genetic findings to the therapy decision

  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

Interventions

molecular genetic analyses DIAGNOSTIC_TEST

molecular genetic analyses

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gynecological tumors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Women's Hospital

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

Study Officials

• Andreas D Hartkopf, Prof

  Department of Women's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 21, 2017
• Study Start: May 29, 2017
• Primary Completion: May 29, 2020
• Study Completion: December 31, 2021
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)