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| Name | Class |
|---|---|
| Broad Institute of MIT and Harvard | OTHER |
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The goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies.
This prospective, single arm study aims to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Investigators hope to learn how to best incorporate routine genetic testing in clinical care for participants with blood cancers, regardless of personal or family history of blood cancer.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, and punch skin biopsies.
It is expected that about 200 people will take part in this research study.
The laboratory sponsor of this protocol is Broad Clinical Laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyeloGen Germline Testing Group | Experimental | Enrolled participants will complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyeloGen Gene Panel | Device | The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful Completion Rate | Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Positive Results | A "positive" result indicating a pathogenic or likely pathogenic variant was detected. This will also include Variants of Unknown Significance (VUSs) with supporting pathogenic criteria per American College of Medical Genetics guidelines (ACMG). | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher R Reilly, MD | Contact | 407-443-6243 | Christopherr_reilly@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher R Reilly, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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 |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Patient Reported Outcome of Germline Genetic Testing based on GST Survey |
Participants will complete the GST survey 1 (after the educational video and skin biopsy) and GST survey 2 between 45-60 days after disclosure of genetic test results. GST survey answers will be converted to a 5-point scale: 1- Disagree strongly, 2-Disagree, 3-Neither Agree or Disagree, 4-Agree, 5- Agree strongly. |
| Up to 60 days |
| Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations | NCCN guideline-based eligibility for germline genetic testing will be assessed using the following criteria and manual review of participants' medical record, 1) Participants with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) less than age 50, 2) Hypoplastic MDS regardless of age; 3) History of aplastic anemia, 4) Documented suspicion of a possible germline predisposition to myeloid malignancies. | Up to 12 weeks |