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Trial Title:
MCW Master Predict (Profile Related Evidence Determining Individualized Cancer Therapy)
NCT ID:
NCT05802069
Condition:
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Froedtert Hospital and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristina Jacobs
Phone:
414-955-3643
Email:
kjacobs@mcw.edu
Start date:
December 19, 2022
Completion date:
December 2027
Lead sponsor:
Agency:
Sameem M. Abedin, MD
Agency class:
Other
Source:
Medical College of Wisconsin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802069
