Gynecologic CancerMAGynMANCT03194347
Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas
An observational study of Gynecologic Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- molecular genetic analyses
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 29 May 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- life expectancy <12 months or worse general condition (Karnofsky <70)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- molecular genetic analyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular genetic analysesDiagnostic test
molecular genetic analyses
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start29 May 2017
- Primary completion29 May 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas D Hartkopf, Prof, Principal investigator, Department of Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194347
- Sponsor's protocol ID
- MAGynMA
- Acronym
- MAGynMA
- Status last verified
- Dec 2024
- First submitted
- 22 May 2017
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas
- ClinicalTrials.gov ID
- NCT03194347
- Acronym / sponsor ID
- MAGynMA / MAGynMA
- Conditions
- Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- life expectancy <12 months or worse general condition (Karnofsky <70)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular genetic analysesmolecular genetic analyses | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas D Hartkopf, Prof principal investigator
Department of Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of molecular genetic findings to the therapy decision (time frame: 3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.