## Protocol Section
### Identification Module
**NCT ID:** NCT06415656

**Brief Title:** VitalTraq for the Detection of CRS

**Official Title:** Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy

#### Organization Study ID Info
**ID:** Pro00115012
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Blue Spark Technologies

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

### Conditions Module

**Conditions:**

- Hematologic Malignancy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 32

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

**Intervention Names:**

- Device: TempTraq

- Device: VitalTraq

**Label:** Patients with hematologic malignancies

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with hematologic malignancies

**Description:** TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.

**Name:** TempTraq

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Patients with hematologic malignancies

**Description:** VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

**Name:** VitalTraq

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers.

**Measure:** TempTraq's ability to measure axillary temperature in the intended use population.

**Time Frame:** Day 14

#### Secondary Outcomes

**Description:** The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature \> 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers.

**Measure:** Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.

**Time Frame:** Day 14

**Description:** Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively.

**Measure:** VitalTraq's ability to measure blood pressure in the intended use population.

**Time Frame:** Day 14

**Description:** Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute.

**Measure:** VitalTraq's ability to measure heart rate in the intended use population.

**Time Frame:** Day 14

**Description:** The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden.

**Measure:** Patient's perspective on the burden of using TempTraq and VitalTraq.

**Time Frame:** Day 28

**Description:** The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring.

**Measure:** Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care.

**Time Frame:** Day 14

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:

   * Axicabtagene ciloleucel
   * Lisocabtagene maraleucel
   * Brexucabtagene autoleucel
   * Idecabtagene vicleucel
   * Ciltacabtagene autoleucel
   * Tisagenlecleucel
   * Blinatumomab
   * Mosunetuzumab
   * Talquetamab
   * Elranatamab
   * Teclistamab
   * Glofitamab
2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.
3. Able to read and understand English
4. Willing and able to provide informed consent to the study

Exclusion Criteria:

1. Receiving a non-FDA approved CAR-T or BiTE product
2. Receiving Epcoritamab

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lauren9494@gmail.com

**Name:** Lauren Hill

**Phone:** 7045774113

**Role:** CONTACT

**Contact 2:**

**Email:** chenyu.lin@duke.edu

**Name:** Chenyu Lin, MD

**Phone:** +1 919 684 8964

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University

**Name:** Chenyu Lin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M21314

- Name: Hematologic Neoplasms

- Relevance: HIGH

- As Found: Hematologic Malignancies

- ID: M2157

- Name: Cytokine Release Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019337

- Term: Hematologic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
