Avera/Sema4 Oncology and Analytics Protocol (ASAP)
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| ClinicalTrials.gov Identifier: NCT05142033 |
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Recruitment Status :
Recruiting
First Posted : December 2, 2021
Last Update Posted : January 31, 2023
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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 |
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| 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 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 |
- Percent of patients participating in comprehensive molecular profiling [ Time Frame: 5 years ]
- Percent of patients referred for cascade genetic testing [ Time Frame: 5 years ]
- Percent of patients referred for molecularly targeted clinical trials [ Time Frame: 5 years ]
- Percent of patients that had therapy changed due to comprehensive molecular profiling [ Time Frame: 5 years ]
- Percent of patients that had therapy changed due to pharmacogenomic testing [ Time Frame: 5 years ]
- Percent of patient participating in microbiome collection and analysis [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
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
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
| Contact: Casey Williams, PharmD | 605-322-3588 | Casey.Williams@avera.org | |
| Contact: Martha Lang, RN | 605-322-3228 | precisionresearch@avera.org |
| 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 | |
| Principal Investigator: | Casey Williams, PharmD | Avera Cancer Institute |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cancer Genomics Genetics Microbiome Pharmacogenomics |
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Endometrial Neoplasms Hematologic Neoplasms Neoplasms by Site Neoplasms 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 |