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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802069
• Other study ID #: PRO00044894
• Status: Recruiting
• Start date: December 19, 2022
• Est. completion date: December 2033

Study information

• Verified date: June 2023
• Source: Medical College of Wisconsin
• Contact: Kristina Jacobs
• Phone: 414-955-3643
• Email: kjacobs[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Sameem M. Abedin, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects receiving precision therapies providing biospecimens of any kind.	Precision therapies are targeted against specific genomic mutations.	One year
Primary	Number of subjects not receiving precision therapies and providing biospecimens.	Precision therapies are targeted against specific genomic mutations.	One year