Status:
RECRUITING
Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Brief Summary
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 d...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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 with valid iOS operating software
- Have a registered MSK MyChart account and be willing to download the MSK Remote Monitoring (RM) application onto their personal iPhone
- 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)
- 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
- Willing to provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
3644 Patients enrolled
Trial Details
Trial ID
NCT05390827
Start Date
May 19 2022
End Date
July 1 2026
Last Update
August 17 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065