UWCCC Molecular Tumor Board Registry

UWCCC Precision Medicine Molecular Tumor Board Registry

This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor Board, and to track patient outcomes.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms; Solid Neoplasm
• Intervention / Treatment: Other: PMMTB (Precision Medicine Molecular Tumor Board)

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Cancer Connect; Phone Number: 8006228922; Email: clinicaltrials@cancer.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin Carbone Cancer Center
      • Principal Investigator: Mark Burkard, PhD
      • Contact: Cancer Connect; Phone Number: 800-622-8922; Email: clinicaltrials@cancer.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include all patients age ≥18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor. It will require each patient to have the ability to understand and willingness to sign a written informed consent document.

Description

Inclusion Criteria:

• Clinically suspected or histologically confirmed solid or hematological malignancy
• Undergoing genetic testing of tumor
• Ability to understand written informed consent document
• Willingness to sign written informed consent document

Exclusion Criteria:

• Pediatric patients (age<18 years) will be excluded due to a lack of expertise on the molecular tumor committee

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PMMTB; This study of the PMMTB will include all patients >= 18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor. All standard of care functions will be performed by standard procedures.	Other: PMMTB (Precision Medicine Molecular Tumor Board); PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of acceptance of molecular tumor board recommendations	How often the molecular tumor board's recommendations are accepted	Up to 5 years
Benefit from PMMTB recommended treatment	Whether patients benefit from PMMTB recommended treatment	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of mutations with protein overexpression	Correlate mutations identified in tumor tissue with protein overexpression	Up to 5 years
Correlations of mutations with circulating tumor DNA	Correlate mutations identified in tumor tissue with circulating tumor DNA	Up to 5 years
Correlations of mutations with spheroid culture investigations	Correlate mutations identified in tumor tissue with spheroid culture investigations	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mark Burkard, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• UW Carbone Cancer Center Home Page

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2016
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: UW15068; P30CA014520 (U.S. NIH Grant/Contract); 2015-1370 (Other Identifier: Institutional Review Board); A533400 (Other Identifier: UW Madison); SMPH\UWCCC\GENERAL (Other Identifier: UW Madison); NCI-2019-06343 (Registry Identifier: NCI Trial ID); 1R37CA226526-01A1 (U.S. NIH Grant/Contract); Protocol Version 11/22/2021 (Other Identifier: UW Madison)

Drug and device information, study documents

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