Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05390827

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 data may relate to cancer diagnosis and response to treatment, and to identify factors that may lead to higher or lower risk of cancer.

Conditions

Solid Tumor

Study ID

NCT05390827

Start date

May 19, 2022

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 (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 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)

Study Design

Enrollment

3692 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Luke Pike, MD, DPhil

212-639-8157jonesl3@mskcc.org

Jessica Scott, PhD

646-888-8093

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Luke Pike, MD, DPhil

212-639-8157

Jessica Scott, PhD

646-888-8093

Principal Investigator:

Luke Pike, MD, DPhil

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Remote Digital Physiological Data Collection
  • Exercise Oncology
  • 20-330

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-21.