MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-29

Study Completion Date

2029-07-01

Brief Summary

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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.

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Detailed Description

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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

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Myeloid Malignancy Myeloid Malignancies Blood Cancer Blood Cancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Germline Genetic Testing

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.

Group Type EXPERIMENTAL

Genetic Blood Test

Intervention Type OTHER

Germline genetic testing using skin fibroblasts

Interventions

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Genetic Blood Test

Germline genetic testing using skin fibroblasts

Intervention Type OTHER

Other Intervention Names

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Custom Hereditary Cancer Gene Panel

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No