Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Cholangiocarcinoma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.

Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information

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

Return of Genetic Results: Biomarker information from cancer cells

Return of Genetic Results: Inherited mutations related to cancer

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

Graham Colditz, M.D., DrPH, MPH

Bettina Drake, Ph.D., MPH

Li Ding, Ph.D.

Bettina Drake, Ph.D.

Ryan Fields, M.D.

Yin Cao, ScD, MPH

Feng Chen, Ph.D.

Kia Davis, ScD, MPH

Patricia Dickson, M.D.

Eric Duncavage, M.D.

Mark Fiala, MSW

Aimee James, Ph.D., MPH

Reyka Jayasinge, Ph.D.

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

Erin Linnenbringer, Ph.D., MS

Jessica Mozersky, Ph.D.

Mary Politi, Ph.D.

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

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

Ravi Vij, M.D., MBA

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

Fei Wan, Ph.D.

Mike Wendl, DSC, MS, PHS

Matthew Wyczalkowsi, Ph.D.

Stephanie Solomon Cargill, Ph.D., MSPH

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.

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

Will share all data, software and know-how generated during the course of this work, without limitations except as prevented by prior agreement. This will include both the final datasets, as well as the data necessary to complete the aims. Will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Wherever applicable, data will be deposited to appropriate public repositories.

All participants whose genomic data are collected will be consented for broad data sharing, and their genomic data will be included in the study deposits. Data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and diagnosis, consistent with applicable laws and regulations.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

The Foundation for Barnes-Jewish Hospital

Washington University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)	NCT06340646	Cholangiocarcin... Multiple Myelom... Colon Cancer Rectal Cancer	Return of Genet... Return of Genet... Return of Genet...	18 Years -	Washington University School of Medicine
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)	NCT06340646	Cholangiocarcin... Multiple Myelom... Colon Cancer Rectal Cancer	Return of Genet... Return of Genet... Return of Genet...	18 Years -	Washington University School of Medicine

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