- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05390827
암의 원격 디지털 생리학적 데이터 수집: MSK 레지스트리 프로토콜
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jessica Scott, PhD
- 전화번호: 646-888-8093
연구 연락처 백업
- 이름: Luke Pike, MD, DPhil
- 전화번호: 212-639-8157
- 이메일: jonesl3@mskcc.org
연구 장소
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New York
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
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연락하다:
- Jessica Scott, PhD
- 전화번호: 646-888-8093
-
연락하다:
- Luke Pike, MD, DPhil
- 전화번호: 212-639-8157
-
수석 연구원:
- Luke Pike, MD, DPhil
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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).
설명
Inclusion Criteria:
Project 1: HealthKit
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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
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≥18 years old
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Own an Apple iPhone or Android with valid operating software
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Self-reported "very well" comprehension of written and verbal English language
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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:
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Patients at MSK who are:
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Scheduled to undergo any type of BMT (Cohort 1)
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Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)
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Scheduled to undergo any surgery for prostate cancer (Cohort 3)
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Scheduled to undergo any lung cancer surgery (Cohort 4)
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Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)
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Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):
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High risk/very high localized, locally advanced,
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Biochemically recurrent prostate cancer
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Treatment naïve, low-volume metastatic prostate cancer
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Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)
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Receiving outpatient care at Memorial Sloan Kettering Cancer Center (MSK)(Cohort 10)
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Diagnosed with metastatic cancer to bone For purposes of this study, metastatic bone disease includes skeletal involvement from multiple myeloma (Cohort 10)
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Scheduled for non-emergent orthopaedic surgery to stabilize lower-extremity bone metastases (Cohort 10)
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Able to undergo at least 5 consecutive days of preoperative monitoring prior to surgery (Cohort 10)
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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)
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Have a ≥50% predicted likelihood of 3-month postoperative survival, as estimated by the PATHFx clinical decision-support tool (Cohort 10
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Individuals without cancer <50 years of age (Cohort 8)
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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
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer
기간: 1 year
|
to create a repository and infrastructure to address novel questions of clinical importance. |
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Luke Pike, MD, DPhil, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20-330
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .