UNIVERSAL GENETIC TESTING OF PATIENTS WITH HEMATOLOGICAL MALIGNANCIES (UGT)

NCT06843291 | Not Yet Recruiting

• 1 other identifier: 2218223
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

We propose to perform NGS and OGM with DNA extracted from bone marrow (BM; site of cancer) and NGS on skin fibroblast DNA (proxy for germline) on all patients with hematologic malignancies (HM) who undergo a standard-of-care BM biopsy at Georgia Cancer Center/Wellstar MCG Health. Simultaneous 4 mm punch skin biopsy for fibroblast culture will be obtained at the planned puncture site of the BM biopsy. The bone marrow biopsy and aspirate are already part of the patient's scheduled medical evaluation and the punch biopsy of the skin is the only additional procedure involved in the study.

Conditions

Hematologic Disease

Keywords

Genetic testing; hematological malignancies

Outcome Measures

Primary Outcomes (1)

• Percentage of all patients with hematological malignancies who agree to undergo genetic testing

  The primary endpoint will be the percentage of all patients with newly diagnosed HMs who undergo BM/fibroblast DNA NGS testing.

  5 years

Study Arms (1)

genetic testing for hematological malignancies

EXPERIMENTAL

Single arm study for patients with hematological malignancies who agree to genetic testing.

Genetic: Genetic Testing for hematological malignancies

Interventions

Genetic Testing for hematological malignancies GENETIC

combined skin punch biopsy/BM aspiration technique, followed by NGS and OGM.

genetic testing for hematological malignancies

Eligibility Criteria

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

You may qualify if:

• \- a. Age ≥ 18 years of age. b. A new diagnosis of HM. c. Diagnostic bone marrow to be performed at Wellstar MCG Health/Georgia Cancer Center.
• d. Ability and willingness to provide informed consent in English to undergo skin biopsy for fibroblast culture and NGS for comparison with the BM NGS.

Sponsors & Collaborators

• Augusta University: lead

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• John Henson, MD

  Medical College of Georgia at Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James T Sonnenberg, BS

CONTACT

9106192597; JSONNENBERG@AUGUSTA.EDU

Eleanor Reeves, BS

CONTACT

7067210730; EREEVES@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 24, 2025

Record last verified: 2025-02