ASAP: Avera/Sema4 Oncology and Analytics Protocol

Sponsor

Avera McKennan Hospital & University Health Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142033

Collaborator

Sema4 (Other)

25,000

Enrollment

Location

Anticipated Duration (Months)

403.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types.

Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing.

In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research.

Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.

Condition or Disease	Intervention/Treatment	Phase
Cancer Cancer Diagnosis Early Detection of Cancer Breast Cancer Lung Cancer Colon Cancer GI Cancer Gynecologic Cancer Ovarian Cancer Endometrial Cancer CNS Cancer Hematologic Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

25000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Implementation of Comprehensive Molecular Profiling and Deep Clinical Annotation of Electronic Health Records in Participants Diagnosed With a Malignancy or at Risk of Developing Cancer

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Outcome Measures

Primary Outcome Measures

Percent of patients participating in comprehensive molecular profiling [5 years]
Percent of patients referred for cascade genetic testing [5 years]
Percent of patients referred for molecularly targeted clinical trials [5 years]

Secondary Outcome Measures

Percent of patients that had therapy changed due to comprehensive molecular profiling [5 years]
Percent of patients that had therapy changed due to pharmacogenomic testing [5 years]
Percent of patient participating in microbiome collection and analysis [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Must be at least 18 years of age
Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer
Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation

Exclusion Criteria:

Participants incapable of understanding the items listed in the consent form and process
Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements