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

NCT ID: NCT05802069

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2027-12-31

Brief Summary

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.

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.

Conditions

Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sameem M. Abedin, MD

OTHER

Sponsor Role: lead

Responsible Party

Sameem M. Abedin, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sameem Abedin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Razelle Kurzrock, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Mary M. Horowitz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristina Jacobs

Role: CONTACT

kjacobs@mcw.edu

414-955-3643

Medical College of Wisconsin Cancer Center Clinical Trials Office

Role: CONTACT

cccto@mcw.edu

866-680-0505 ext. 8900

Facility Contacts

Kristina Jacobs

Role: primary

kjacobs@mcw.edu

414-955-3643

Other Identifiers

PRO00044894

Identifier Type: -

Identifier Source: org_study_id