- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01813825
A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
연구 개요
상태
개입 / 치료
상세 설명
PURPOSE OF STUDY
The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.
PROCEDURES
If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.
POTENTIAL RISKS AND DISCOMFORTS
There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team.
POTENTIAL BENEFITS:
It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others.
ALTERNATIVES TO TREATMENT
The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Deborah Fang, MD
- 전화번호: 203-576-5085
연구 장소
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Connecticut
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Bridgeport, Connecticut, 미국, 06606
- 모병
- St. Vincent's Medical Center
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연락하다:
- Deborah Fang, MD
-
수석 연구원:
- Deborah Fang, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Be 45 years of age or older
- Be a Tis, T1, N0 M0 - American Joint Committee Classification
- Have negative surgical margins (NSABP definition) after final surgery
- Should have adequate skin spacing between balloon surface and surface of the skin (>=7mm)
- DCIS
Exclusion Criteria:
- Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
- Have collagen-vascular disease
- Have extensive intraductal component (Harvard Definition,>25% DCIS)
- Have infiltrating lobular histology
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Female >=45 years, negative margins, DCIS
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
기간: 1-4 weeks
|
The efficacy of the treatment will be measured by using the overall survival.
The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.
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1-4 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Deborah Fang, MD, St. Vincent's Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- SVMC 104
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. .
기재에 대한 임상 시험
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University Hospital, Basel, Switzerland완전한
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University of Wisconsin, MadisonNational Institute on Aging (NIA)완전한