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

  • STATUS
    Recruiting
  • End date
    May 14, 2023
  • participants needed
    3096
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 14 July 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 96 patients. 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 chimeric antigen receptor (CAR) T-cell therapy, (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, (7) individuals without a history of cancer aged less than 50 years, and (8) individuals without a history of cancer aged greater than or equal to 50 years. This study will accrue patients receiving care at any MSK site.

Details
Condition Solid Tumor
Clinical Study IdentifierNCT05390827
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals who meet one of the following criteria
Diagnosis of new onset early-stage (I-III) solid tumor within 6 months of initial recruitment approach (Cohort 1: Pre-treatment / during adjuvant therapy)
Diagnosis of primary invasive solid tumor from 2017 onwards (Cohort 2: Post-definitive adjuvant treatment)
Diagnosis of new onset metastatic (stage IV) solid tumor within 6 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
Scheduled to undergo any type of BMT at MSK (Cohort 1)
Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy at MSK (Cohort 2)
Scheduled to initiate CAR T Cell therapy at MSK (Cohort 3)
Scheduled to undergo any lung cancer surgery at MSK (Cohort 4)
Scheduled to undergo TNT for locally advanced rectal cancer at MSK (Cohort 5)
High risk/very high localized, locally advanced, biochemically recurrent, or treatment naïve, low-volume metastatic prostate cancer scheduled to initiate
Scheduled to initiate antiandrogen therapy for locally advanced prostate cancer at MSK (Cohort 6)
Individuals without cancer <50 years of age (Cohort 7)
Individuals without cancer ≥50 years of age (Cohort 8)
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 informed consent

Exclusion Criteria

Unable or unwilling to appropriately use digital platforms or devices
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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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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