NCT05390827 · Memorial Sloan Kettering Cancer Center
Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol
What this study is about
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.
View original scientific description
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.
Primary outcome measures
establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer
Time frame: 1 year
to create a repository and infrastructure to address novel questions of clinical importance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 with valid iOS operating software
- Have a registered MSK MyChart account
- 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 (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 6-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
- 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)
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations