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Molecular Tumor Board at the Center for Personalized Medicine Tübingen (MTB@ZPM)

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ClinicalTrials.gov Identifier: NCT03503149
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Molecular Tumor Board at the Center for Personalized Medicine

Condition or disease Intervention/treatment
Advanced Cancer Other: no intervention

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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2028
Estimated Study Completion Date : March 1, 2028

Intervention Details:
  • Other: no intervention
    observational study


Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
    Progression-free survival


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: an average of 1 year ]
    Progression-free survival


Biospecimen Retention:   Samples With DNA
Tumor tissue, blood tisssue


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced stages of cancer
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03503149


Contacts
Contact: Ghazaleh Tabatabai, Prof 0049707129 ext 83269 ghazaleh.tabatabai@med.uni-tuebingen.de
Contact: Nisar P Malek, Prof 0049707129 ext 83269 ghazaleh.tabatabai@med.uni-tuebingen.de

Locations
Germany
University Hospital Tübingen Recruiting
Tübingen, BW, Germany, 72076
Contact: Ghazaleh Tabatabai, Prof    0049707129 ext 83269    ghazaleh.tabatabai@med.uni-tuebingen.de   
Contact: Nisar P Malek, Prof    0049707129 ext 83269    ghazaleh.tabatabai@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Ghazaleh Tabatabai, Prof University Hospital Tübingen

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03503149     History of Changes
Other Study ID Numbers: ZPM-001
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: only within a publication

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