Clinical trial NCT04889937: Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Official title: A Study to Evaluate the Usability, Adherence and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancy
Lead sponsor: Leuko Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Center for Advancing Point of Care Technologies
First posted: 2021-05-17
Enrollment: 46
Sex: ALL
Minimum age (years): 7
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in children, and adults diagnosed with cancer that require cytotoxic chemotherapies that could lead to febrile neutropenia. Patients with Diffuse Large B-Cell Non-Hodgkin Lymphoma (DLBCL) and breast cancer who are scheduled to receive cytotoxic chemotherapy agents with high (\>20%) or intermediate (10-20%) risk of neutropenia will be the main target. However, all adult patients with Hodgkin/Non-Hodgkin Lymphoma and breast cancer and all children with solid or liquid tumors (see inclusion and exclusion criteria) whose therapy has an intermediate or high-risk of febrile neutropenia, are eligible. The main factor to select the populations will therefore be the estimated risk of severe neutropenia from the chemotherapy used. Patients under any other regimen that have an associated FN risk greater than 10% will be considered eligible.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Usability of PointCheck
timeFrame: Up to three-weeks
Secondary outcomes:
measure: Accuracy of PointCheck
timeFrame: Up to three-weeks
measure: Repeatability of PointCheck
timeFrame: Up to three-weeks
measure: Number of participants with device-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to three-weeks
measure: Adherence to PointCheck
timeFrame: Up to three-weeks
Other outcomes:
measure: Predictive capacity of PointCheck
timeFrame: Up to three-weeks
measure: Diagnostic performance for a second cutoff
timeFrame: Up to three-weeks
measure: Clinical Utility Assessment
timeFrame: Up to three-weeks
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Branko Cuglievan, MD
role: PRINCIPAL_INVESTIGATOR
References: