Clinical trial NCT05802069: MCW Master Predict (Profile Related Evidence Determining Individualized Cancer Therapy)
Official title: Medical College of Wisconsin Master Predict (Profile Related Evidence Determining Individualized Cancer)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Number of subjects receiving precision therapies providing biospecimens of any kind.
timeFrame: One year
measure: Number of subjects not receiving precision therapies and providing biospecimens.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sameem Abedin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Razelle Kurzrock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Mary M. Horowitz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: