Solid TumorNCT05390827
Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol
An observational study of Solid Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- How many people
- 3,692 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 39Show fewer
- 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 For purposes of this study, metastatic bone disease includes skeletal involvement from multiple myeloma (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 3-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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Scott, PhD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Luke Pike, MD, DPhil, 212-639-8157
Jessica Scott, PhD, 646-888-8093
About this study
Official title: 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.
Read the 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 168 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, and 10 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. and (10) patients scheduled to undergo surgery for metastatic bone disease.
For Cohort 10 (patients scheduled to undergo surgery for metastatic bone disease), an expanded DigIT-Ex sub-study will be conducted. This sub-study will enroll up to 40 patients with metastatic cancer to bone of the lower extremity who are undergoing non-emergent orthopaedic stabilization surgery. Participants will be monitored longitudinally for functional activity using wearable activity monitors for a minimum of 5 days prior to surgery and for up to 4 months following surger 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.
- Conditions
- Solid Tumor
- Keywords
- Remote Digital Physiological Data Collection, Exercise Oncology, 20-330
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start19 May 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,692 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Pike, MD, DPhil, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390827
- Sponsor's protocol ID
- 20-330
- Status last verified
- Sep 2026
- First submitted
- 20 May 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol
- ClinicalTrials.gov ID
- NCT05390827
- Acronym / sponsor ID
- 20-330
- Conditions
- Solid Tumor
- Keywords
- Remote Digital Physiological Data Collection, Exercise Oncology, 20-330
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,692 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 168 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, and 10 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. and (10) patients scheduled to undergo surgery for metastatic bone disease.
For Cohort 10 (patients scheduled to undergo surgery for metastatic bone disease), an expanded DigIT-Ex sub-study will be conducted. This sub-study will enroll up to 40 patients with metastatic cancer to bone of the lower extremity who are undergoing non-emergent orthopaedic stabilization surgery. Participants will be monitored longitudinally for functional activity using wearable activity monitors for a minimum of 5 days prior to surgery and for up to 4 months following surger 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (39 listed)
- Project 1: HealthKit
- Individuals who meet at least one of the following criteria:
- ≥18 years old
- Own an Apple iPhone or Android with valid operating software
- Self-reported "very well" comprehension of written and verbal English language
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Solid Tumor
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Scott, PhD contact
Luke Pike, MD, DPhil principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luke Pike, MD, DPhil (212-639-8157, jonesl3@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.