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Recruiting

NCT Number: NCT06340646

Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)

The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.

Recruiting

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Blood Protein Disorders Carcinoma Cardiovascular Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Paraproteinemias Rectal Cancer Rectal Diseases Rectal Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Aimee James, Ph.D., MPH

SUB_INVESTIGATOR

Bettina Drake, Ph.D.

SUB_INVESTIGATOR

Bettina Drake, Ph.D., MPH

CONTACT

[email protected]

314-747-4534

David Spencer, M.D., Ph.D.

SUB_INVESTIGATOR

Eric Duncavage, M.D.

SUB_INVESTIGATOR

Erin Linnenbringer, Ph.D., MS

SUB_INVESTIGATOR

Fei Wan, Ph.D.

SUB_INVESTIGATOR

Feng Chen, Ph.D.

SUB_INVESTIGATOR

Graham Colditz, M.D., DrPH, MPH

CONTACT

[email protected]

314-454-7939

Graham Colditz, M.D., DrPH, MPH

PRINCIPAL_INVESTIGATOR

Jessica Mozersky, Ph.D.

SUB_INVESTIGATOR

Kian-Huat Lim, M.D., Ph.D.

SUB_INVESTIGATOR

Li Ding, Ph.D.

SUB_INVESTIGATOR

Mark Fiala, MSW

SUB_INVESTIGATOR

Mark Watson, M.D., Ph.D.

SUB_INVESTIGATOR

Mary Politi, Ph.D.

SUB_INVESTIGATOR

Matthew Wyczalkowski, Ph.D.

SUB_INVESTIGATOR

Mike Wendl, DSC, MS, PHS

SUB_INVESTIGATOR

Patricia Dickson, M.D.

SUB_INVESTIGATOR

Ravi Vij, M.D., MBA

SUB_INVESTIGATOR

Reyka Jayasinge, Ph.D.

SUB_INVESTIGATOR

Ryan Fields, M.D.

SUB_INVESTIGATOR

Stephanie Solomon Cargill, Ph.D., MSPH

SUB_INVESTIGATOR

Tunji Toriola, M.D., Ph.D., MPH

SUB_INVESTIGATOR

Yin Cao, ScD, MPH

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Eligibility Criteria:

  • Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.
  • If diagnosed with multiple myeloma, must be African-American.
  • If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.
  • At least 18 years old
  • Able to understand and willing to sign an IRB-approved written informed consent document

Treatment and study plan

Return of Genetic Results: Biomarker information from cancer cells

Other

Participants will receive a novel return of results report that is tailored to their choices.

Return of Genetic Results: Inherited mutations related to cancer

Other

Participants will receive a novel return of results report that is tailored to their choices.

Return of Genetic Results: Inherited mutations related to other medical issues

Other

Participants will receive a novel return of results report that is tailored to their choices.

Primary outcomes

  1. Participant knowledge of clinical genetic testing

    Time frame: Through completion of follow-up (estimated to be 5 years)

    11-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-11) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, and 5) are reverse scored so that 'strongly agree' reflects a correct response and 'somewhat agree' reflect a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 5 to 55. A higher score for the participant represents higher participant knowledge.

  2. Participant expectations of benefit

    Time frame: Through completion of follow-up (estimated to be 5 years)

    Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree. This will be scored by adding up the numbers for each of the 8 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations.

  3. Participant personal utility

    Time frame: Through completion of follow-up (estimated to be 5 years)

    Participant personal utility will be measured on a 7-point scale ranging from not at all useful to extremely useful. 1=Not at all useful, 2=A little useful, 3=Somewhat useful, 4=Neutral, 5=Useful, 6=Very useful, 7=Extremely useful. This will be scored by adding up the numbers for each of the 14 items regarding participant personal utility. The total score ranges from 14 to 98. A higher score for the participant represents higher personal utility.

Secondary outcomes

  1. Participant anxiety

    Time frame: Through completion of follow-up (estimated to be 5 years)

    Participant anxiety will be measured using a 5-point Likert scale ranging from not at all to very much. 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much. This will be scored by adding up the numbers for each of the 6 items regarding participant cancer worry. The total score ranges from 0 to 24. A higher score for the participant represents higher participant cancer worry.

  2. Participant satisfaction

    Time frame: Through completion of follow-up (estimated to be 5 years)

    Satisfaction will be measured using a 5-point Likert scale ranging from extremely satisfied to not at all. 1=Not at all satisfied, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Extremely satisfied. The total score ranges from 1 to 5. A higher score for the participant represents higher participant satisfaction.

Study contacts

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

Bettina Drake, Ph.D., MPH

CONTACT

[email protected]

314-747-4534

Graham Colditz, M.D., DrPH, MPH

CONTACT

[email protected]

314-454-7939

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • The Foundation for Barnes-Jewish Hospital

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Jul 14, 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.

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