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AzTrials

CancerASAPNCT05142033

Avera Cancer Sequencing and Analytics Protocol (ASAP)

An observational study of Cancer and Cancer Diagnosis, run by Avera McKennan Hospital & University Health Center at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
25,000 participants
Where
6 sitesUnited States
Study dates
1 Nov 2021to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Participants with a premalignant or malignant condition and able/willing to consent/participate in the study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Elsey, PharmD contact

605-322-3225

Rachel.Elsey@avera.org

Avera Precision Research Team contact

888-422-1410

McK-MBX-PrecisionResearch@avera.org

6 sites in 1 country

United States6 sites, 6 recruiting

  • Avera Cancer Institute - Aberdeen

    Aberdeen, South Dakota, 57401

    Rachel Elsey, PharmD, 605-322-3225, Rachel.Elsey@avera.org

    Recruiting

  • Avera Cancer Institute - Marshall

    Marshall, Minnesota, 56258

    Rachel Elsey, PharmD, 605-322-3225, rachel.elsey@avera.org

    Recruiting

  • Avera Cancer Institute - Mitchell

    Mitchell, South Dakota, 57301

    Rachel Elsey, PharmD, 605-322-3225, rachel.elsey@avera.org

    Recruiting

  • Avera Cancer Institute - Pierre

    Pierre, South Dakota, 57501

    Rachel Elsey, PharmD, 605-322-3225, rachel.elsey@avera.org

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Rachel Elsey, PharmD, 605-322-3225, Rachel.Elsey@avera.org

    Recruiting

  • Avera Cancer Institute - Yankton

    Yankton, South Dakota, 57078

    Rachel Elsey, PharmD, 605-322-3225, rachel.elsey@avera.org

    Recruiting

Other trials in United States

About this study

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)

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.

Read more

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.

Keywords
Cancer, Genomics, Genetics, Microbiome, Pharmacogenomics
Medical subject headings
Neoplasms, Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Central Nervous System Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of patients participating in comprehensive molecular profiling

    Measured: 5 years

  2. Percent of patients referred for cascade genetic testing

    Measured: 5 years

  3. Percent of patients referred for molecularly targeted clinical trials

    Measured: 5 years

Secondary outcomes (3)

  1. Percent of patients that had therapy changed due to comprehensive molecular profiling

    Measured: 5 years

  2. Percent of patients that had therapy changed due to pharmacogenomic testing

    Measured: 5 years

  3. Percent of patient participating in microbiome collection and analysis

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start1 Nov 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
25,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142033
Sponsor's protocol ID
ASAP Protocol
Acronym
ASAP
Status last verified
Oct 2026
First submitted
4 Nov 2021
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nakagawa H, Fujita M. Whole genome sequencing analysis for cancer genomics and precision medicine. Cancer Sci. 2018 Mar;109(3):513-522. doi: 10.1111/cas.13505. Epub 2018 Feb 26.

    PubMed 29345757

  • Yi T, Feng Y, Sundaram R, Tie Y, Zheng H, Qian Y, You D, Yi T, Wang P, Zhao X. Antitumor efficacy of PARP inhibitors in homologous recombination deficient carcinomas. Int J Cancer. 2019 Sep 1;145(5):1209-1220. doi: 10.1002/ijc.32143. Epub 2019 Feb 23.

    PubMed 30666631

  • Lee B, Tran B, Hsu AL, Taylor GR, Fox SB, Fellowes A, Marquis R, Mooi J, Desai J, Doig K, Ekert P, Gaff C, Herath D, Hamilton A, James P, Roberts A, Snyder R, Waring P, McArthur G. Exploring the feasibility and utility of exome-scale tumour sequencing in a clinical setting. Intern Med J. 2018 Jul;48(7):786-794. doi: 10.1111/imj.13806.

    PubMed 29607586

  • Reda M, Richard C, Bertaut A, Niogret J, Collot T, Fumet JD, Blanc J, Truntzer C, Desmoulins I, Ladoire S, Hennequin A, Favier L, Bengrine L, Vincent J, Hervieu A, Dusserre JG, Lepage C, Foucher P, Borg C, Albuisson J, Arnould L, Nambot S, Faivre L, Boidot R, Ghiringhelli F. Implementation and use of whole exome sequencing for metastatic solid cancer. EBioMedicine. 2020 Jan;51:102624. doi: 10.1016/j.ebiom.2019.102624. Epub 2020 Jan 7.

    PubMed 31923800

  • Beltran H, Eng K, Mosquera JM, Sigaras A, Romanel A, Rennert H, Kossai M, Pauli C, Faltas B, Fontugne J, Park K, Banfelder J, Prandi D, Madhukar N, Zhang T, Padilla J, Greco N, McNary TJ, Herrscher E, Wilkes D, MacDonald TY, Xue H, Vacic V, Emde AK, Oschwald D, Tan AY, Chen Z, Collins C, Gleave ME, Wang Y, Chakravarty D, Schiffman M, Kim R, Campagne F, Robinson BD, Nanus DM, Tagawa ST, Xiang JZ, Smogorzewska A, Demichelis F, Rickman DS, Sboner A, Elemento O, Rubin MA. Whole-Exome Sequencing of Metastatic Cancer and Biomarkers of Treatment Response. JAMA Oncol. 2015 Jul;1(4):466-74. doi: 10.1001/jamaoncol.2015.1313.

    PubMed 26181256

  • Samimi G, Bernardini MQ, Brody LC, Caga-Anan CF, Campbell IG, Chenevix-Trench G, Couch FJ, Dean M, de Hullu JA, Domchek SM, Drapkin R, Spencer Feigelson H, Friedlander M, Gaudet MM, Harmsen MG, Hurley K, James PA, Kwon JS, Lacbawan F, Lheureux S, Mai PL, Mechanic LE, Minasian LM, Myers ER, Robson ME, Ramus SJ, Rezende LF, Shaw PA, Slavin TP, Swisher EM, Takenaka M, Bowtell DD, Sherman ME. Traceback: A Proposed Framework to Increase Identification and Genetic Counseling of BRCA1 and BRCA2 Mutation Carriers Through Family-Based Outreach. J Clin Oncol. 2017 Jul 10;35(20):2329-2337. doi: 10.1200/JCO.2016.70.3439. Epub 2017 Apr 11.

    PubMed 28398847

  • Win AK, Jenkins MA, Dowty JG, Antoniou AC, Lee A, Giles GG, Buchanan DD, Clendenning M, Rosty C, Ahnen DJ, Thibodeau SN, Casey G, Gallinger S, Le Marchand L, Haile RW, Potter JD, Zheng Y, Lindor NM, Newcomb PA, Hopper JL, MacInnis RJ. Prevalence and Penetrance of Major Genes and Polygenes for Colorectal Cancer. Cancer Epidemiol Biomarkers Prev. 2017 Mar;26(3):404-412. doi: 10.1158/1055-9965.EPI-16-0693. Epub 2016 Oct 31.

    PubMed 27799157

  • Maxwell KN, Domchek SM, Nathanson KL, Robson ME. Population Frequency of Germline BRCA1/2 Mutations. J Clin Oncol. 2016 Dec;34(34):4183-4185. doi: 10.1200/JCO.2016.67.0554. Epub 2016 Oct 31. No abstract available.

    PubMed 27551127

  • 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.

    PubMed 28632866

  • Peltomaki P. Update on Lynch syndrome genomics. Fam Cancer. 2016 Jul;15(3):385-93. doi: 10.1007/s10689-016-9882-8.

    PubMed 26873718

  • Kurian AW, Ward KC, Howlader N, Deapen D, Hamilton AS, Mariotto A, Miller D, Penberthy LS, Katz SJ. Genetic Testing and Results in a Population-Based Cohort of Breast Cancer Patients and Ovarian Cancer Patients. J Clin Oncol. 2019 May 20;37(15):1305-1315. doi: 10.1200/JCO.18.01854. Epub 2019 Apr 9.

    PubMed 30964716

  • Knerr S, Bowles EJA, Leppig KA, Buist DSM, Gao H, Wernli KJ. Trends in BRCA Test Utilization in an Integrated Health System, 2005-2015. J Natl Cancer Inst. 2019 Aug 1;111(8):795-802. doi: 10.1093/jnci/djz008.

    PubMed 30753636

  • O'Donnell PH, Dolan ME. Cancer pharmacoethnicity: ethnic differences in susceptibility to the effects of chemotherapy. Clin Cancer Res. 2009 Aug 1;15(15):4806-14. doi: 10.1158/1078-0432.CCR-09-0344. Epub 2009 Jul 21.

    PubMed 19622575

  • Shaw DM, Elger BS, Colledge F. What is a biobank? Differing definitions among biobank stakeholders. Clin Genet. 2014 Mar;85(3):223-7. doi: 10.1111/cge.12268. Epub 2013 Oct 16.

    PubMed 24001330

  • UK Biobank data on 500,000 people paves way to precision medicine. Nature. 2018 Oct;562(7726):163-164. doi: 10.1038/d41586-018-06950-9. No abstract available.

    PubMed 30365879

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Cancer Diagnosis, run by Avera McKennan Hospital & University Health Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Elsey, PharmD (605-322-3225, Rachel.Elsey@avera.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of patients participating in comprehensive molecular profiling (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05142033, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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