RECRUITING

Avera Cancer Sequencing and Analytics Protocol (ASAP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2021-11-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05142033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be at least 18 years of age
  2. * Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer
  3. * Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation
  1. * Participants incapable of understanding the items listed in the consent form and process
  2. * Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements

Contacts and Locations

Study Contact

Rachel Elsey, PharmD
CONTACT
605-322-3225
Rachel.Elsey@avera.org
Martha Lang, RN
CONTACT
605-322-3228
precisionresearch@avera.org

Principal Investigator

Rachel Elsey, PharmD
PRINCIPAL_INVESTIGATOR
Avera Cancer Institute

Study Locations (Sites)

Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, 57401
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States

Collaborators and Investigators

Sponsor: Avera McKennan Hospital & University Health Center

  • Rachel Elsey, PharmD, PRINCIPAL_INVESTIGATOR, Avera Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Genomics
  • Genetics
  • Microbiome
  • Pharmacogenomics

Additional Relevant MeSH Terms

  • 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