NCT05390827

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,644

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2022Jul 2027

Study Start

First participant enrolled

May 19, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

May 20, 2022

Last Update Submit

February 6, 2026

Conditions

Keywords

Remote Digital Physiological Data CollectionExercise Oncology20-330

Outcome Measures

Primary Outcomes (1)

  • establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer

    to create a repository and infrastructure to address novel questions of clinical importance.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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
  • +19 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

Study Officials

  • Luke Pike, MD, DPhil

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Pike, MD, DPhil

CONTACT

Jessica Scott, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

May 19, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations