MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies

NCT06543511 | Withdrawn

• 1 other identifier: 24-087
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myeloid Malignancy; Myeloid Malignancies; Blood Cancer; Blood Cancers

Keywords

Myeloid Malignancy; Myeloid Malignancies; Blood Cancer; Blood Cancers

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Participant Knowledge of Genetic Testing Pre-Education

  At baseline

• Participant Knowledge of Genetic Testing Post-Education

  At baseline, following pre-educational video

• Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1

  At baseline

• Participant Satisfaction Score on GTS Survey 2

  Up to 130 days from baseline

• Multidimensional Impact of Cancer Risk Assessment (MICRA) Score

  Up to 130 days from baseline

Study Arms (1)

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.

Other: Genetic Blood Test

Interventions

Genetic Blood Test OTHER

Germline genetic testing using skin fibroblasts

Also known as: Custom Hereditary Cancer Gene Panel

Germline Genetic Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christopher Reilly, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu