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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390827
• Other study ID #: 20-330
• Status: Recruiting
• Start date: May 19, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Lee Jones, PhD
• Phone: 646-888-8103
• Email: jonesl3[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 risk of cancer.

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 diagnosed from 2015 onwards 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 Baseline Medical History Questionnaire (BMH) as part of standard intake in an MSK care 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3644
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 within 24 months of initial recruitment approach

• Diagnosis of primary invasive solid tumor from 2015 onwards

• 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 Baseline Medical History (BMH) Questionnaire

• Adult without a history of cancer <50 years of age

• Adult without a history of cancer = 50 years of age

• 18 to 90 years old

• Own an Apple iPhone with valid iOS operating software

• Have the MyMSK app downloaded on their iPhone or be willing to download the MyMSK app

• Willing to provide informed consent

• Self-reported "very well" comprehension of written and verbal English language

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 share physiological data

Project 2: DigIT-Ex

• Unable or unwilling to appropriately use digital platforms or devices

Related Conditions & MeSH terms

• Solid Tumor

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center