Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer
Background:
Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.
Objective:
To collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.
Eligibility:
People aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.
Design:
Participants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.
Participants will come to the NIH clinic to have their samples collected:
- Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.
- Blood.
- Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.
- Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.
Participants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples.
연구 개요
상세 설명
Background
- Breast cancer (BC) is the most common cancer among women and the second leading cause of cancer-related deaths in women.
- Among the four common metastatic sites of BC - liver, lung, bone, and brain - brain metastases result in the most severe adverse effects and poorest survival outcomes.
- Despite robust preclinical data on potential drugs for brain metastasis prevention, designing prevention trials remains challenging due to the difficulty of identifying high-risk populations, the long time required for outcomes to develop, and the associated costs.
- Circulating-tumor DNA (ctDNA) from cerebrospinal fluid (CSF) collected from patients who had been locally treated for brain metastases and showed no evidence of metastases on MRI displayed a distinct mutation profile compared to plasma collected at the same time.
Primary Objective
-To collect CSF samples from participants with metastatic triple negative breast cancer (TNBC) and HER2+ breast cancer (BC) with no prior history nor active radiographically detectable brain metastases
Eligibility
- Confirmed metastatic HER2+ BC or TNBC
- Age >=18 years
Design
- This pilot, single-site tissue collection trial aims to collect CSF samples for analysis as potential predictors of brain metastases.
- CSF, blood, tumor tissue, and saliva or buccal mucosa will be collected at baseline and optionally during the study.
- All participants will be followed up for brain metastasis development every 6 months for up to 3 years.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ann C McCoy, R.N.
- 전화번호: (240) 760-6021
- 이메일: ann.mccoy@nih.gov
연구 연락처 백업
- 이름: Takeo Fujii, M.D.
- 전화번호: (240) 858-3558
- 이메일: takeo.fujii@nih.gov
연구 장소
-
-
Maryland
-
Bethesda, Maryland, 미국, 20892
- 모병
- National Institutes of Health Clinical Center
-
연락하다:
- National Cancer Institute Referral Office
- 전화번호: 888-624-1937
- 이메일: ncimo_referrals@mail.nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
- INCLUSION CRITERIA:
- Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.
- Participants must be able to undergo lumbar puncture (LP) and brain MRI.
- Women age >= 18 years
Adequate organ function as defined below:
- Creatinine <=1.5 x institutional upper limit of normal (ULN)
OR
--Calculated Creatinine clearance >=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
- Participants must be able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA:
- Prior history or current MRI-detected brain metastasis or leptomeningeal disease
- Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cohort 1
Participants with metastatic triple negative breast cancer (mTNBC) without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy
|
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
|
|
Cohort 2
Participants with metastatic HER2+ BC without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy
|
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
|
|
Cohort 3
Participants with newly diagnosed mTNBC without a history or active radiographically detectable CNS disease and without prior systemic therapies
|
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
|
|
Cohort 4
Participants with newly diagnosed metastatic HER2+ BC without a history or active radiographically detectable CNS disease and without prior systemic therapies
|
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Collection of CSF samples
기간: Up to 3 years
|
CSF samples from participants with metastatic triple negative breast cancer (TNBC) and HER2+ breast cancer (BC) with no prior history nor active radiographically detectable brain metastases will be collected to perform downstream analyses will be collected and summarized/described descriptively.
|
Up to 3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Takeo Fujii, M.D., National Cancer Institute (NCI)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- 10002493
- 002493-C
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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