Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05142033

Avera Cancer Sequencing and Analytics Protocol (ASAP)

The purpose of this study is to characterize the breadth of molecular features present in participants receiving care within a large, integrated, community-based healthcare system. Through comprehensive genomic profiling, investigators aim to identify the underlying genomic drivers of premalignant and malignant conditions across a range of disease stages and cancer types.

Comprehensive molecular profiling will include somatic tumor testing (tissue and/or blood) using next-generation sequencing. Selected subsets of samples may undergo whole exome and/or whole transcriptome sequencing for research purposes. Pharmacogenomic testing will also be performed to better understand individual variability in medication response and to identify opportunities for optimizing treatment. In addition, participants may optionally provide microbiome samples.

To maximize the value of the genomic data, participants who consent to this protocol will have their electronic health records-both retrospective and prospective-abstracted, curated, annotated, and linked to the genomic data generated through study testing. Given the long-term value of these data, participants may also voluntarily consent to the storage of their biological samples in a biobank and to the use of their de-identified information for future research.

Data collected from this participant population will support efforts to advance the understanding of cancer biology, as well as the discovery and validation of biomarkers associated with clinical outcomes. Findings may also be shared through collaborative research initiatives to further promote advancements in cancer research.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms CNS Cancer Cancer Diagnosis Central Nervous System Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Early Detection of Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GI Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Gynecologic Cancer Hematologic Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Cancer Institute - Marshall, Marshall, Minnesota, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Avera Precision Research Team

CONTACT

[email protected]

888-422-1410

Rachel Elsey, PharmD

CONTACT

[email protected]

605-322-3225

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study title

Implementation of Comprehensive Molecular Profiling and Deep Clinical Annotation of Electronic Health Records in Participants Diagnosed With or at Risk of Developing Cancer (ASAP Study)

Acronym: ASAP

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.