NCT07570056

Brief Summary

The goal of this project is to test non-invasive, painless skin electrical bioimpedance (BioZ) measurements as an adjunctive biomarker to standard bone marrow biopsies.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Mar 2027

First Submitted

Initial submission to the registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Myelodysplastic SyndromesAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Correlate BioZ findings with Pathologic Results

    The primary outcome measure of this study is to correlate BioZ findings with pathologic results from bone marrow biopsies with AML or MDS.

    up to one day

Study Arms (1)

Patients with Suspected or AML or MDS

BioZ measurements will take about 1 minute to complete. The measurement will be completed 3 times.

Diagnostic Test: Bioimpedance (BioZ)

Interventions

Bioimpedance (BioZ)DIAGNOSTIC_TEST

The BioZ device uses a low-intensity electrical current that is applied from inside of the BioZ device that has small electrodes at the tip. To interrogate these electrical properties, the electrodes (tip of the device) will be placed on the skin in the area of the hip. Once this occurs, the electrodes will be activated and the low-intensity current will be applied. As the current moves through the skin the device has a probe to detect changes in current that may be associated with cancer. Data from the probe is related to a secure phone that has an app to collect information.

Patients with Suspected or AML or MDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or confirmed diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

You may qualify if:

  • Suspected or confirmed diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and undergoing a bone marrow biopsy.
  • Age 18 or older.
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

You may not qualify if:

  • Study prospect that has an electronic implant (cardiac, neurological, sensory, prosthetic implants with an electronic component. Also monitoring and drug delivery systems.)
  • Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
  • Pregnant women
  • Inability to understand and/or speak the English or Spanish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Talati C, Sweet K. Recently approved therapies in acute myeloid leukemia: A complex treatment landscape. Leuk Research 73:58-66,2018.

    BACKGROUND

  • Bain BJ. Bone marrow biopsy morbidity: review of 2003. J Clin Pathol 58(4):406-8, 2005.

    BACKGROUND

  • Andreasen N et al,. Machine learning-based diagnosis of breast cancer and evaluation of therapy effect measuring skin electrical resistance in lymphatic regions. IEEE Access, 2021, 9: 152322-152332.

    BACKGROUND

  • Luo X et al. Electrical characterization of basal cell carcinoma using a novel handheld electrical impedance spectroscopy device. Journal of Investigative Dermatology Innovations, 2022, 2 (1), 100075.

    BACKGROUND

  • Wong E et al. Electrical impedance dermography differentiates squamous cell carcinoma in situ from inflamed seborrheic keratoses. Journal of Investigative Dermatology Innovations, 3 (3), 100194, 2023.

    BACKGROUND

  • Hansen N et al. Tongue electrical impedance myography correlates with functional, neurophysiologic, and clinical outcome measures in long-term oropharyngeal cancer survivors with and without hypoglossal neuropathy: an exploratory study. Head & Neck. 2024 Mar;46(3):581-591

    BACKGROUND

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Paul Shami, MD

    Huntsman Cancer Institute/ University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Shami, MD

CONTACT

801-585-5136paul.shami@utah.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share