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

  • STATUS
    Recruiting
  • End date
    May 18, 2024
  • participants needed
    3108
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 18 October 2022

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. The targeted patient cohorts / settings will be (n=1000/cohort): (1) pre-treatment / during adjuvant therapy: patients with newly diagnosed early-stage solid tumors that are either pre- or during adjuvant therapy, (2) post-treatment: patients who completed definitive adjuvant therapy, and (3) metastatic setting: patients diagnosed with metastatic (stage IV) disease. This study will accrue patients receiving care at any MSK site.

Project 2: DigIT-Ex This prospective registry cohort study will aim to recruit a total of 84 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort): (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.

Details
Condition Solid Tumor
Clinical Study IdentifierNCT05390827
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Project 1: HealthKit
Individuals who meet one of the following criteria
Diagnosis of new onset early-stage (I-III) solid tumor within 12 months of initial recruitment approach (Cohort 1: Pre-treatment / during adjuvant therapy)
Diagnosis of primary invasive solid tumor from 2015 onwards (Cohort 2: Post-definitive adjuvant treatment)
Diagnosis of new onset metastatic (stage IV) solid tumor within 12 months of initial recruitment approach (Cohort 3: Metastatic setting)
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
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
to 90 years old at the time of consent
Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)
Willing and able to download the Withings Health Mate app onto their personal mobile device
Individuals without cancer <50 years of age (Cohort 8)
Willing to provide informed consent
Individuals without cancer ≥50 years of age (Cohort 9)
Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent

Exclusion Criteria

Unable or unwilling to appropriately use digital platforms or devices
Project 1: HealthKit
Unable or unwilling to successfully export and share physiological data
Project 2: DigIT-Ex
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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