Molecular Tumor Board at the Center for Personalized Medi... | NCT03503149

Studies
Molecular Tumor Board at the Center for Personalized Medicine Tübingen

NCT03503149

Sponsor

University Hospital Tuebingen

Status

Recruiting

Last Update Posted

Apr 19, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Advanced Cancer

Interventions

no intervention

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Apr 18, 2018

First Posted Date

Apr 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	observational study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with advanced stages of cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ghazaleh Tabatabai, Prof	Contact	0049707129	83269	ghazaleh.tabatabai@med.uni-tuebingen.de
Nisar P Malek, Prof	Contact	0049707129	83269	ghazaleh.tabatabai@med.uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Ghazaleh Tabatabai, Prof	University Hospital Tübingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tübingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

only within a publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided