TY - JOUR
T1 - Mainstream germline genetic testing in men with metastatic prostate cancer
T2 - design and protocol for a multicenter observational study
AU - Vlaming, Michiel
AU - Bleiker, Eveline M.A.
AU - van Oort, Inge M.
AU - Kiemeney, Lambertus A.L.M.
AU - Ausems, Margreet G.E.M.
N1 - Funding Information:
This work was supported by the Dutch Cancer Society (KWF), grant number 12601. The study protocol has undergone full external peer review as part of the funding process. The funding body had no role in the design of this study and will have no role in the collection, analysis, and interpretation of the data, and writing of this manuscript.
Publisher Copyright:
© 2022, The Author(s).
© 2022. The Author(s).
PY - 2022/12/30
Y1 - 2022/12/30
N2 - Background: In international guidelines, germline genetic testing is recommended for patients with metastatic prostate cancer. Before undergoing germline genetic testing, these patients should receive pre-test counseling. In the standard genetic care pathway, pre-test counseling is provided by a healthcare professional of a genetics department. Because the number of patients with metastatic prostate cancer is large, the capacity in the genetics departments might be insufficient. Therefore, we aim to implement so-called mainstream genetic testing in the Netherlands for patients with metastatic prostate cancer. In a mainstream genetic testing pathway, non-genetic healthcare professionals discuss and order germline genetic testing. In our DISCOVER study, we will assess the experiences among patients and non-genetic healthcare professionals with this new pathway. Methods: A multicenter prospective observational cohort study will be conducted in 15 hospitals, in different regions of the Netherlands. We developed an online training module on genetics in prostate cancer and the counseling of patients. After completion of this module, non-genetic healthcare professionals will provide pre-test counseling and order germline genetic testing in metastatic prostate cancer patients. Both non-genetic healthcare professionals and patients receive three questionnaires. We will determine the experience with mainstream genetic testing, based on satisfaction and acceptability. Patients with a pathogenic germline variant will also be interviewed. We will determine the efficacy of the mainstreaming pathway, based on time investment for non-genetic healthcare professionals and the prevalence of pathogenic germline variants. Discussion: This study is intended to be one of the largest studies on mainstream genetic testing in prostate cancer. The results of this study can improve the mainstream genetic testing pathway in patients with prostate cancer. Trial registration: The study is registered in the WHO’s International Clinical Trials Registry Platform (ICTRP) under number NL9617.
AB - Background: In international guidelines, germline genetic testing is recommended for patients with metastatic prostate cancer. Before undergoing germline genetic testing, these patients should receive pre-test counseling. In the standard genetic care pathway, pre-test counseling is provided by a healthcare professional of a genetics department. Because the number of patients with metastatic prostate cancer is large, the capacity in the genetics departments might be insufficient. Therefore, we aim to implement so-called mainstream genetic testing in the Netherlands for patients with metastatic prostate cancer. In a mainstream genetic testing pathway, non-genetic healthcare professionals discuss and order germline genetic testing. In our DISCOVER study, we will assess the experiences among patients and non-genetic healthcare professionals with this new pathway. Methods: A multicenter prospective observational cohort study will be conducted in 15 hospitals, in different regions of the Netherlands. We developed an online training module on genetics in prostate cancer and the counseling of patients. After completion of this module, non-genetic healthcare professionals will provide pre-test counseling and order germline genetic testing in metastatic prostate cancer patients. Both non-genetic healthcare professionals and patients receive three questionnaires. We will determine the experience with mainstream genetic testing, based on satisfaction and acceptability. Patients with a pathogenic germline variant will also be interviewed. We will determine the efficacy of the mainstreaming pathway, based on time investment for non-genetic healthcare professionals and the prevalence of pathogenic germline variants. Discussion: This study is intended to be one of the largest studies on mainstream genetic testing in prostate cancer. The results of this study can improve the mainstream genetic testing pathway in patients with prostate cancer. Trial registration: The study is registered in the WHO’s International Clinical Trials Registry Platform (ICTRP) under number NL9617.
KW - Genetic counseling
KW - Germline genetic testing
KW - Mainstream genetic testing
KW - Prostate cancer
KW - Germ Cells/pathology
KW - Prostatic Neoplasms/genetics
KW - Prospective Studies
KW - Genetic Testing
KW - Humans
KW - Male
KW - Genetic Counseling/methods
KW - Multicenter Studies as Topic
KW - Germ-Line Mutation
KW - Observational Studies as Topic
UR - http://www.scopus.com/inward/record.url?scp=85145149223&partnerID=8YFLogxK
U2 - 10.1186/s12885-022-10429-2
DO - 10.1186/s12885-022-10429-2
M3 - Article
C2 - 36581909
AN - SCOPUS:85145149223
SN - 1471-2407
VL - 22
SP - 1
EP - 9
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 1365
ER -