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Recopilación remota de datos fisiológicos digitales en cáncer: un protocolo de registro de MSK

28 de septiembre de 2026 actualizado por: Memorial Sloan Kettering Cancer Center

The purpose of this study is to develop a secure method of collecting physiologic information from patients with cancer. The researchers will use this information to learn more about how physiologic data may relate to cancer diagnosis and response to treatment, and to identify factors that may lead to higher or lower risk of cancer.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

Project 1: HealthKit This prospective registry cohort study will aim to recruit a total of 3,000 patients and 500 adults without a history of cancer. The targeted patient cohorts / settings will aim to be : (1) pre-treatment / during treatment: patients with newly diagnosed early-stage, low-grade, or locally advanced solid tumors that are either pre- or during treatment, (2) post-treatment: patients with primary solid tumor diagnose is that are post-treatment, (3) advanced disease setting: patients diagnosed with metastatic or high-grade disease, (4) patients enrolled onto investigational trials in the early drug development (EDD) Service, (5) patients admitted to Urgent Care Center (UCC), and (6) patients completing a Survivorship Patient Self-Assessment as part of follow-up in an MSK Survivorship clinic. This study will accrue patients receiving care at any MSK site. Adults without a history of cancer will be recruited as a comparison group. The targeted adults without a history of cancer cohorts will aim to be (n=250/cohort): (7) adults without a history of cancer <50 years of age, and (8) adults without a history of cancer aged greater than or equal to 50 years.

Project 2: DigIT-Ex This prospective registry cohort study will aim to recruit a total of 168 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, and 10 which will be (n=48): (1) patients scheduled to undergo bone marrow transplantation, (2) patients newly diagnosed with acute myeloid leukemia (AML), (3) patients scheduled to undergo surgery for localized prostate cancer (4) patients scheduled to undergo surgery for lung cancer, (5) patients scheduled to undergo total neoadjuvant therapy for advanced rectal cancer, (6) patients scheduled to undergo antiandrogen therapy for advanced prostate cancer, and (7) patients scheduled to undergo chemotherapy for metastatic pancreatic cancer. and (10) patients scheduled to undergo surgery for metastatic bone disease.

For Cohort 10 (patients scheduled to undergo surgery for metastatic bone disease), an expanded DigIT-Ex sub-study will be conducted. This sub-study will enroll up to 40 patients with metastatic cancer to bone of the lower extremity who are undergoing non-emergent orthopaedic stabilization surgery. Participants will be monitored longitudinally for functional activity using wearable activity monitors for a minimum of 5 days prior to surgery and for up to 4 months following surger The targeted adults without a history of cancer cohorts will be (n=12/cohort): (8) individuals without a history of cancer aged less than 50 years, and (9) individuals without a history of cancer aged greater than or equal to 50 years.

Tipo de estudio

De observación

Inscripción (Estimado)

3692

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jessica Scott, PhD
  • Número de teléfono: 646-888-8093

Copia de seguridad de contactos de estudio

  • Nombre: Luke Pike, MD, DPhil
  • Número de teléfono: 212-639-8157
  • Correo electrónico: jonesl3@mskcc.org

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10065
        • Reclutamiento
        • Memorial Sloan Kettering Cancer Center
        • Contacto:
          • Jessica Scott, PhD
          • Número de teléfono: 646-888-8093
        • Contacto:
          • Luke Pike, MD, DPhil
          • Número de teléfono: 212-639-8157
        • Investigador principal:
          • Luke Pike, MD, DPhil

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Potential participants will be identified by a member of the patient's care team, a protocol investigator, or research staff at Memorial Sloan Kettering Cancer Center (MSK).

Descripción

Inclusion Criteria:

Project 1: HealthKit

  • Individuals who meet at least one of the following criteria:

    • Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor
    • Historical diagnosis of primary invasive solid tumor
    • Diagnosis of metastatic (stage IV) or high-grade (III-IV) disease
    • Enrolled onto an investigational trial in the EDD Service
    • Seen in the MSK UCC from 2021 and onwards
    • Completion of Survivorship Patient Self-Assessment
    • Adult without a history of cancer <50 years of age
    • Adult without a history of cancer ≥ 50 years of age
  • ≥18 years old

  • Own an Apple iPhone or Android with valid operating software

  • Self-reported "very well" comprehension of written and verbal English language

  • Willing and able to provide informed consent and HIPAA authorization for the release of personal health information

Project 2: DigIT-Ex

Individuals who meet one of the following criteria:

  • Patients at MSK who are:

  • Scheduled to undergo any type of BMT (Cohort 1)

  • Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)

  • Scheduled to undergo any surgery for prostate cancer (Cohort 3)

  • Scheduled to undergo any lung cancer surgery (Cohort 4)

  • Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)

  • Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):

  • High risk/very high localized, locally advanced,

  • Biochemically recurrent prostate cancer

  • Treatment naïve, low-volume metastatic prostate cancer

  • Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)

  • Receiving outpatient care at Memorial Sloan Kettering Cancer Center (MSK)(Cohort 10)

  • Diagnosed with metastatic cancer to bone For purposes of this study, metastatic bone disease includes skeletal involvement from multiple myeloma (Cohort 10)

  • Scheduled for non-emergent orthopaedic surgery to stabilize lower-extremity bone metastases (Cohort 10)

  • Able to undergo at least 5 consecutive days of preoperative monitoring prior to surgery (Cohort 10)

  • Have had a CT scan including the L3 vertebral level within 3 months before surgery (used to assess skeletal muscle mass and sarcopenia) (Cohort 10)

  • Have a ≥50% predicted likelihood of 3-month postoperative survival, as estimated by the PATHFx clinical decision-support tool (Cohort 10

  • Individuals without cancer <50 years of age (Cohort 8)

  • Individuals without cancer ≥50 years of age (Cohort 9)

    • 18 to 90 years old at the time of consent
    • Willing and able to download the Withings Health Mate app onto their personal mobile device
    • Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent for Cohorts 1-9, and 4 months following consent for Cohort 10.
    • Willing to provide informed consent

Exclusion Criteria:

Project 1: HealthKit

  • Unable or unwilling to successfully export and /or share physiological data

Project 2: DigIT-Ex

  • Unable or unwilling to appropriately use digital platforms or devices
  • Require a wheelchair for ambulation (Cohort 10)
  • Are undergoing stabilization surgery for a primary bone tumor (rather than metastatic disease) (Cohort 10)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer
Periodo de tiempo: 1 year

to create a repository and infrastructure to address novel questions of clinical importance.

1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Luke Pike, MD, DPhil, Memorial Sloan Kettering Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de mayo de 2022

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2022

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2022

Publicado por primera vez (Actual)

25 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20-330

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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