UWCCC Molecular Tumor Board Registry

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03023202
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1,500
• Location: 1
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematologic Neoplasms; Solid Neoplasm	Other: PMMTB (Precision Medicine Molecular Tumor Board)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1500 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: UWCCC Precision Medicine Molecular Tumor Board Registry
• Actual Study Start Date: Mar 30, 2016
• Anticipated Primary Completion Date: Mar 1, 2027
• Anticipated Study Completion Date: Mar 1, 2027

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Frequency of acceptance of molecular tumor board recommendations [Up to 5 years]

   How often the molecular tumor board's recommendations are accepted

2. Benefit from PMMTB recommended treatment [Up to 5 years]

   Whether patients benefit from PMMTB recommended treatment

Secondary Outcome Measures

1. Correlation of mutations with protein overexpression [Up to 5 years]

   Correlate mutations identified in tumor tissue with protein overexpression

2. Correlations of mutations with circulating tumor DNA [Up to 5 years]

   Correlate mutations identified in tumor tissue with circulating tumor DNA

3. Correlations of mutations with spheroid culture investigations [Up to 5 years]

   Correlate mutations identified in tumor tissue with spheroid culture investigations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mark Burkard, MD, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UW Carbone Cancer Center Home Page

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03023202
• Other Study ID Numbers: UW15068; 2015-1370; P30CA014520; A533400; SMPH\UWCCC\GENERAL; NCI-2019-06343; 1R37CA226526-01A1; Protocol Version 11/22/2021
• First Posted: Jan 18, 2017
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Jul 11, 2022