Advanced CancerMTB@ZPMNCT03503149
Molecular Tumor Board at the Center for Personalized Medicine Tübingen
An observational study of Advanced Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Molecular Tumor Board at the Center for Personalized Medicine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 1 Mar 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with advanced stages of cancer
Who may be able to join
- Given informed consent ("broad consent" of the University Hospital Tübingen)
- ≥ 18 years of age
- Clinical indication for a referral to Molecular Tumor Board by the treating physician
Who cannot join
- The MTB assists the referring physician with the interpretation and the use of tumor molecular profiling data for deciding on a therapeutic strategy. Therefore, this board is confined to cancer patients and cannot provide any service for non-cancer patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Ghazaleh Tabatabai, Prof, 0049707129 ext. 83269, ghazaleh.tabatabai@med.uni-tuebingen.de
Nisar P Malek, Prof, 0049707129 ext. 83269, ghazaleh.tabatabai@med.uni-tuebingen.de
About this study
Official title: Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study
Molecular Tumor Board at the Center for Personalized Medicine
Read the detailed description
Molecular Tumor Board at the Center for Personalized Medicine The study objectives are
- To ensure a prospective documentation of all patients who are referred to the Molecular Tumor Board in routine clinical care
- To prospectively ensure the documentation of MTB patients with an emphasis to clinical outcome parameters progression-free survival (PFS), overall survival (OS) and further response assessments (e.g. peripheral immunmonitoring, imaging parameters)
- To prospectively assess patient-reported outcome of MTB patients
- To evaluate compliance to MTB suggestions in routine clinical care
- Conditions
- Advanced Cancer
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: 6 months
Secondary outcomes (1)
Overall survival
Progression-free survival
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghazaleh Tabatabai, Prof, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503149
- Sponsor's protocol ID
- ZPM-001
- Acronym
- MTB@ZPM
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only within a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03503149
- Acronym / sponsor ID
- MTB@ZPM / ZPM-001
- Conditions
- Advanced Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 19 Apr 2018 (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.
Molecular Tumor Board at the Center for Personalized Medicine
Detailed description
Molecular Tumor Board at the Center for Personalized Medicine The study objectives are
- To ensure a prospective documentation of all patients who are referred to the Molecular Tumor Board in routine clinical care
- To prospectively ensure the documentation of MTB patients with an emphasis to clinical outcome parameters progression-free survival (PFS), overall survival (OS) and further response assessments (e.g. peripheral immunmonitoring, imaging parameters)
- To prospectively assess patient-reported outcome of MTB patients
- To evaluate compliance to MTB suggestions in routine clinical care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced stages of cancer
Key inclusion criteria (3 listed)
- Given informed consent ("broad consent" of the University Hospital Tübingen)
- ≥ 18 years of age
- Clinical indication for a referral to Molecular Tumor Board by the treating physician
Key exclusion criteria (1 listed)
- The MTB assists the referring physician with the interpretation and the use of tumor molecular profiling data for deciding on a therapeutic strategy. Therefore, this board is confined to cancer patients and cannot provide any service for non-cancer patients
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 |
|---|---|---|
| no interventionobservational study | Other | – |
Primary outcome
Progression-free survival
Time frame: 6 months
Progression-free survival
1 secondary outcome
Overall survival
Time frame: an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided. only within a publication
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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.
Ghazaleh Tabatabai, Prof principal investigator
University Hospital Tuebingen
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 Advanced 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 3 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: looking for participants now, as of the sponsor's last update on 19 Apr 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghazaleh Tabatabai, Prof (0049707129 ext. 83269, ghazaleh.tabatabai@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months). 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 19 Apr 2018.