NCT03023202

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Mar 2016Mar 2029

Study Start

First participant enrolled

March 30, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

12.9 years

First QC Date

January 13, 2017

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Correlation of mutations with protein overexpression

    Up to 5 years

  • Correlations of mutations with circulating tumor DNA

    Up to 5 years

  • Correlations of mutations with spheroid culture investigations

    Up to 5 years

Study Arms (1)

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)

Interventions

PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.

PMMTB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will be asked to give one blood sample and up to two tissue samples (one at diagnossi \& one at progression of treatment, which are both standard clinical procedures). * Drawing 8 tsp of blood at the first clinic visit, DNA extraction from this blood, additional testing on this blood. * Retention of residual tumor tissue for future research. * Collection of residual fresh tumor tissue \[that was biopsied for clinical reasons\], and performing of genetic analyses/retention for future research. * Banking of data, blood, and biopsy tissue for future research. * Distribution of banked data/blood/biopsied tissue for research projects.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Dustin Deming, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

March 30, 2016

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations