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Contractual issues. Will be re-submitted as new protocol.
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This research study is evaluating the feasibility of conducting cancer genetic testing using healthy skin cells among participants with a diagnosis of a blood cancer. Additionally, investigators will evaluate how often participants with blood cancers are found to have risk for cancer based on family genes.
The purpose of this prospective, non-randomized, non-therapeutic, single arm study is to determine the feasibility and benefit of performing genetic testing for all participants with a blood cancer diagnosis regardless of clinical suspicion.
Research study procedures include screening for eligibility, in-clinic visits, questionnaires, and skin punch biopsies. Participants will receive germline genetic testing with a comprehensive hereditary cancer gene panel.
It is expected that about 200 individuals with blood cancer will take part in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Germline Genetic Testing | Experimental | Participants will be enrolled and will complete study procedures as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic Blood Test | Other | Germline genetic testing using skin fibroblasts |
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| Measure | Description | Time Frame |
|---|---|---|
| Genetic Testing Completion Rate | Feasibility is defined as a minimum of 75% of consented participants complete germline genetic testing with the return of test results within 10 weeks of study consent. | Up to 63 months |
| Incidence Rate of Positive Genetic Results | Defined as the proportion of participants with a "positive" result on the germline genetic testing. Positive results equal Variants classified as Pathogenic (P), Likely pathogenic (LP), or Variants of Uncertain Significance (VUS) with supporting pathogenic criteria. | Up to 63 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Knowledge of Genetic Testing Pre-Education | Assessed by the KnowGene6 questionnaire, a 6-question survey assessing participant understanding of inherited genetic risk. Responses will be summarized by question and the number of correct answers will be compared. | At baseline |
| Participant Knowledge of Genetic Testing Post-Education |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Reilly, MD | Dana-Farber Cancer Institute | Principal Investigator |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Assessed by the KnowGene6 questionnaire, a 6-question survey assessing participant understanding of inherited genetic risk. Responses will be summarized by question and the number of correct answers will be compared. |
| At baseline, following pre-educational video |
| Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1 | Assessed by the Genetic Testing Satisfaction (GTS) 1, a 10-item measure rated on a 5-point scale from 1 "Strongly Disagree" to 5 "Agree Strongly" with a total scores range of 10 to 50. A higher score represents greater participant satisfaction. | At baseline |
| Participant Satisfaction Score on GTS Survey 2 | Assessed by the Genetic Testing Satisfaction (GTS) 2, a 10-item measure rated on a 5-point scale from 1 "Strongly Disagree" to 5 "Agree Strongly" with a total scores range of 10 to 50. A higher score represents greater participant satisfaction. | Up to 130 days from baseline |
| Multidimensional Impact of Cancer Risk Assessment (MICRA) Score | Assessed by the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire to measure the psychological impact of testing over the past week, and comprised of 25 question which are rated on a 4-point scale from 1 "Never" to 4 "Often" with a total scores range of 25 to 100. A higher score represents greater psychological impact. | Up to 130 days from baseline |
| Participant Decisional Regret Score | Assessed by the Decisional Regret Survey to measure the degree of participant regret in choosing to undergo germline genetic testing, and comprised of 5 questions rated on a 5-point scale from 1 "Strongly Agree" to 5 "Strongly Disagree" with a total scores range of 5 to 25. A higher score represents greater regret. | Up to 130 days from baseline |
| Detection Rate of Germline Predisposition | Defined as the number of participants with an identified germline predisposition on genetic testing who would not have met National Comprehensive Cancer Network (NCCN) guideline-based germline genetic testing recommendations. | Up to 63 months |
| Impact of Genetic Results on Clinical Decision-Making | Assessed by the Primary Clinician Survey, a 5-question survey including 4 questions with graded answers (Strongly Agree, Agree, Neither, Disagree, Strongly Disagree) and 1 free text question for overall study feedback. | Up to 130 days from baseline |