Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population (PC004)

Leuko Labs

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Device: PointCheck

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04889937

MDACC Protocol ID: 2021-0061

Details and patient eligibility

About

Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.

Enrollment: 46 patients

Sex: All

Ages: 7 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Study subjects, or their parent/legal guardian for subjects <18 years, must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects between the ages of 7 and 17.9 years must provide assent.
2. Male or Female aged 7 years to 65 years.
3. Adults (> 18 years) diagnosed Diagnosed with Hodgkin/Non-Hodgkin Lymphoma or breast cancer.
4. Children and adolescents (7 - 18 years) with liquid or solid tumors.
5. Scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia (table 1) 30.
6. Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria

1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease, or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
3. Participants with circulating tumor cells in previous or current lab determinations.
4. Adult (>18 years) participants with leukemia of all types and pediatric (7-18 years) participants with leukemia that are either not in remission or in the minimal residual disease category.
5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
6. Unstable participants (pediatric or adults) or adult participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
7. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
8. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Trial design

46 participants in 1 patient group

PC004 Cohort

Description:

The study will include a sample of patients with specific cancer types visiting the outpatient hematologic oncology clinic for their standard of care chemotherapy administration. Participants will need to be willing to participate and be able to provide written informed consent

Treatment:

Device: PointCheck