Myeloid MalignancyNCT06543511
MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
A study testing Genetic Blood Test in people with Myeloid Malignancy and Myeloid Malignancies, run by Dana-Farber Cancer Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Malignancy, Myeloid Malignancies, Blood Cancer
- What is being tested?
- Genetic Blood Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2024to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
- Ability to understand and provide a signed and completed consent document in English or Spanish.
Who cannot join
- Patients with who cannot safely undergo skin biopsy as adjudicated by the study team.
- Patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies
About this study
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.
Read the detailed description
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.
- Conditions
- Myeloid Malignancy, Myeloid Malignancies, Blood Cancer, Blood Cancers
- Being tested
- Genetic Blood Test
- Keywords
- Myeloid Malignancy, Myeloid Malignancies, Blood Cancer, Blood Cancers
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Blood TestOther
Also called Custom Hereditary Cancer Gene Panel
Germline genetic testing using skin fibroblasts
| Study group | Role | What they receive |
|---|---|---|
| Germline Genetic Testing | Experimental | Participants will be enrolled and will complete study procedures as follows:
* Baseline visit with educational video and questionnaires.
* Skin punch biopsy.
* Genetic testing results.
* Surveys and questionnaires.
* Follow up via medical records for up to 2 years from time of study consent. Receives: Other: Genetic Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 63 months
Secondary outcomes (8)
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.
Measured: At baseline
Participant Knowledge of Genetic Testing Post-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 130 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start29 Jul 2024 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Why it stopped: Contractual issues. Will be re-submitted as new protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid MalignancyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Reilly, Dana-Farber Cancer Institute
- Investigators
- Christopher Reilly, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543511
- Sponsor's protocol ID
- 24-087
- Status last verified
- Nov 2024
- First submitted
- 5 Aug 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT06543511
- Acronym / sponsor ID
- 24-087
- Conditions
- Myeloid Malignancy, Myeloid Malignancies, Blood Cancer, Blood Cancers
- Keywords
- Myeloid Malignancy, Myeloid Malignancies, Blood Cancer, Blood Cancers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contractual issues. Will be re-submitted as new protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 29 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Germline Genetic Testing | Experimental | Other: Genetic Blood TestParticipants will be enrolled and will complete study procedures as follows: * Baseline visit with educational video and questionnaires. * Skin punch biopsy. * Genetic testing results. * Surveys and questionnaires. * Follow up via medical records for up to 2 years from time of study consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older
- Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
- Ability to understand and provide a signed and completed consent document in English or Spanish.
Key exclusion criteria (2 listed)
- Patients with who cannot safely undergo skin biopsy as adjudicated by the study team.
- Patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic Blood TestAlso: Custom Hereditary Cancer Gene PanelGermline genetic testing using skin fibroblasts | Other | Germline Genetic Testing |
Primary outcome
Genetic Testing Completion Rate
Time frame: Up to 63 months
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.
Incidence Rate of Positive Genetic Results
Time frame: Up to 63 months
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.
8 secondary outcomes
Participant Knowledge of Genetic Testing Pre-Education
Time frame: At baseline
Participant Knowledge of Genetic Testing Post-Education
Time frame: At baseline, following pre-educational video
Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1
Time frame: At baseline
Participant Satisfaction Score on GTS Survey 2
Time frame: Up to 130 days from baseline
Multidimensional Impact of Cancer Risk Assessment (MICRA) Score
Time frame: Up to 130 days from baseline
Participant Decisional Regret Score
Time frame: Up to 130 days from baseline
Detection Rate of Germline Predisposition
Time frame: Up to 63 months
Impact of Genetic Results on Clinical Decision-Making
Time frame: Up to 130 days from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Reilly, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Blood Test in people with Myeloid Malignancy and Myeloid Malignancies, run by Dana-Farber Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Testing Completion Rate (time frame: Up to 63 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.