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

Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study

Molecular Tumor Board at the Center for Personalized Medicine

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: 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
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ghazaleh Tabatabai, Prof; Phone Number: 83269 0049707129; Email: ghazaleh.tabatabai@med.uni-tuebingen.de
• Study Contact Backup: Name: Nisar P Malek, Prof; Phone Number: 83269 0049707129; Email: ghazaleh.tabatabai@med.uni-tuebingen.de

Study Locations

• Germany
  • BW
    • Tübingen, BW, Germany, 72076
      • Recruiting
      • University Hospital Tubingen
      • Contact: Ghazaleh Tabatabai, Prof; Phone Number: 83269 0049707129; Email: ghazaleh.tabatabai@med.uni-tuebingen.de
      • Contact: Nisar P Malek, Prof; Phone Number: 83269 0049707129; Email: ghazaleh.tabatabai@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced stages of cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Progression-free survival	an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Ghazaleh Tabatabai, Prof, University Hospital Tubingen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 1, 2028
• Study Completion (Anticipated): March 1, 2028

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ZPM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: only within a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No