NCT05390827 Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol
| NCT ID | NCT05390827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,692 participants |
| Start Date | 2022-05-19 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,692 participants in total. It began in 2022-05-19 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Luke Pike, MD, DPhil
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05390827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05390827 currently recruiting?
Yes, NCT05390827 is actively recruiting participants. Contact the research team at jonesl3@mskcc.org for enrollment information.
Where is the NCT05390827 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05390827 clinical trial?
NCT05390827 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Luke Pike, MD, DPhil at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 3,692 participants.