- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638007
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment (TKI)
연구 개요
상태
상세 설명
PRIMARY OBJECTIVE:
I. Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ashley Mack, MS
- 전화번호: 585-275-1090
- 이메일: URCC_24060@urmc.rochester.edu
연구 장소
-
-
New York
-
Rochester, New York, 미국, 14642
- 모병
- University of Rochester NCORP Research Base
-
연락하다:
- Ashley Mack
- 전화번호: 585 - 275 - 1361
- 이메일: URCC_24060@urmc.rochester.edu
-
수석 연구원:
- Karen Mustian, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
- TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
- TKI RECIPIENTS: Participants must be ≥ 18 years of age
- TKI RECIPIENTS: Participants must be able to speak and read English
- TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant)
Exclusion Criteria:
- Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
- Participants must have no history of TKI therapy
- Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
- Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
- Participants must have no history of head trauma with loss of consciousness within the year prior to consent
- Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning
- Participants must have no psychiatric condition that led to hospitalization within the past year
- Participants must not be currently pregnant
- Participants must not be colorblind based on self-report
- Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Observational group I
TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
|
|
Observational group II
Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subjective cognitive performance
기간: 12 months
|
Will be assessed using the FACT-Cog.
Will apply multilevel models to study data.
Will include main effects of time, group, and the group X time interaction.
|
12 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Michelle Janelsins, PhD, University of Rochester NCORP Research Base
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- URCC-24060 (기타 식별자: CTEP)
- UG1CA189961 (미국 NIH 보조금/계약)
- R01CA287666 (미국 NIH 보조금/계약)
- NCI-2025-04174 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .