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Avera/Sema4 Oncology and Analytics Protocol (ASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05142033
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : January 31, 2023
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

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
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

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Study Type : Observational
Estimated 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 : November 1, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Percent of patients participating in comprehensive molecular profiling [ Time Frame: 5 years ]
  2. Percent of patients referred for cascade genetic testing [ Time Frame: 5 years ]
  3. Percent of patients referred for molecularly targeted clinical trials [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Percent of patients that had therapy changed due to comprehensive molecular profiling [ Time Frame: 5 years ]
  2. Percent of patients that had therapy changed due to pharmacogenomic testing [ Time Frame: 5 years ]
  3. Percent of patient participating in microbiome collection and analysis [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Retention: Samples with DNA/RNA, and protein Description: Tissue, blood, stool, saliva, skin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participants with a premalignant or malignant condition and able/willing to consent/participate in the study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142033

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Contact: Casey Williams, PharmD 605-322-3588 Casey.Williams@avera.org
Contact: Martha Lang, RN 605-322-3228 precisionresearch@avera.org

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United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Casey Williams, PharmD    605-322-3588    Casey.Williams@avera.org   
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
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Principal Investigator: Casey Williams, PharmD Avera Cancer Institute
Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium; McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112.

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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT05142033    
Other Study ID Numbers: AVS4TL - 0921
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avera McKennan Hospital & University Health Center:
Additional relevant MeSH terms:
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Endometrial Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Uterine Neoplasms
Uterine Diseases
Hematologic Diseases