- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05390827
Raccolta di dati fisiologici digitali a distanza nel cancro: un protocollo di registro MSK
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jessica Scott, PhD
- Numero di telefono: 646-888-8093
Backup dei contatti dello studio
- Nome: Luke Pike, MD, DPhil
- Numero di telefono: 212-639-8157
- Email: jonesl3@mskcc.org
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10065
- Reclutamento
- Memorial Sloan Kettering Cancer Center
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Contatto:
- Jessica Scott, PhD
- Numero di telefono: 646-888-8093
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Contatto:
- Luke Pike, MD, DPhil
- Numero di telefono: 212-639-8157
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Investigatore principale:
- Luke Pike, MD, DPhil
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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).
Descrizione
Inclusion Criteria:
Project 1: HealthKit
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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
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≥18 years old
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Own an Apple iPhone or Android with valid operating software
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Self-reported "very well" comprehension of written and verbal English language
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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:
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Patients at MSK who are:
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Scheduled to undergo any type of BMT (Cohort 1)
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Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)
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Scheduled to undergo any surgery for prostate cancer (Cohort 3)
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Scheduled to undergo any lung cancer surgery (Cohort 4)
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Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)
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Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):
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High risk/very high localized, locally advanced,
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Biochemically recurrent prostate cancer
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Treatment naïve, low-volume metastatic prostate cancer
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Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)
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Receiving outpatient care at Memorial Sloan Kettering Cancer Center (MSK)(Cohort 10)
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Diagnosed with metastatic cancer to bone For purposes of this study, metastatic bone disease includes skeletal involvement from multiple myeloma (Cohort 10)
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Scheduled for non-emergent orthopaedic surgery to stabilize lower-extremity bone metastases (Cohort 10)
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Able to undergo at least 5 consecutive days of preoperative monitoring prior to surgery (Cohort 10)
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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)
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Have a ≥50% predicted likelihood of 3-month postoperative survival, as estimated by the PATHFx clinical decision-support tool (Cohort 10
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Individuals without cancer <50 years of age (Cohort 8)
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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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer
Lasso di tempo: 1 year
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to create a repository and infrastructure to address novel questions of clinical importance. |
1 year
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Luke Pike, MD, DPhil, Memorial Sloan Kettering Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 20-330
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
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