Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol

February 6, 2026 updated by: Memorial Sloan Kettering Cancer Center

Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol

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.

Study Overview

Status

Recruiting

Conditions

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 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 120 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, 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. 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.

Study Type

Observational

Enrollment (Estimated)

3644

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jessica Scott, PhD
  • Phone Number: 646-888-8093

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Jessica Scott, PhD
          • Phone Number: 646-888-8093
        • Contact:
          • Luke Pike, MD, DPhil
          • Phone Number: 212-639-8157
        • Principal Investigator:
          • Luke Pike, MD, DPhil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Luke Pike, MD, DPhil, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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