MCW Master Predict (Profile Related Evidence Determining Individualized Cancer Therapy)

Medical College of Wisconsin Master Predict (Profile Related Evidence Determining Individualized Cancer)

The study is an observational trial for patients undergoing cancer-related interventions and therapy at Medical College of Wisconsin Cancer Center. Projects under this protocol will use patient data that will be collected both retrospectively and prospectively. It will also enable prospective sample collection for specific cancer-related studies.

Study Overview

• Status: Recruiting
• Conditions: Cancer

Detailed Description

This is a master protocol that enables investigators to conduct observational research and correlative biospecimen studies. This study is non-therapeutic, with retrospective and prospective components. This will be a single-site study at MCW/FH. Retrospective data and, with consent, prospective observational data will be collected. The study will also include an opportunity for patients to consent to the analysis of specimens collected prospectively during care and for the collection of research-related testing of blood, stool, and/or urine. It is designed to decrease the burden on both patients and investigators by allowing consent to a protocol that will enable multiple minimal-risk studies.

Studies under this master protocol may perform data analysis using standard statistical techniques, as well as with advanced bioinformatics, machine learning, artificial intelligence, and other related technologies.

Collection and testing of biospecimens will only be performed if a proposed study that falls under this master protocol requires it. Studies may include a variety of simple or advanced techniques related to chemical, hematologic, molecular, proteomic, transcriptomic, immunomic, and metabolic analyses, as well as related multi-omic analysis for biomarker discovery, understanding correlations between treatment and molecular features, and/or for pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu
• Study Contact Backup: Name: Kristina Jacobs; Phone Number: 414-955-3643; Email: kjacobs@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital and the Medical College of Wisconsin
      • Contact: Kristina Jacobs; Phone Number: 414-955-3643; Email: kjacobs@mcw.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

Patients aged 18 years and older who were previously or are currently receiving care for a cancer-related condition at MCW/FH. Newly diagnosed cancer patients at MCW/FH will also be considered. Patients must be willing and able to give informed consent for any prospective data or specimen collection.

Description

Inclusion Criteria:

• Subjects aged 18 years and older who were previously or are currently receiving care for a cancer-related condition at MCW/FH.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects receiving precision therapies providing biospecimens of any kind.	Precision therapies are targeted against specific genomic mutations.	One year
Number of subjects not receiving precision therapies and providing biospecimens.	Precision therapies are targeted against specific genomic mutations.	One year

Collaborators and Investigators

• Sponsor: Sameem M. Abedin, MD
• Investigators: Principal Investigator: Mary M. Horowitz, MD, MS, Medical College of Wisconsin; Principal Investigator: Sameem Abedin, MD, Medical College of Wisconsin; Principal Investigator: Razelle Kurzrock, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRO00044894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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