- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02368106
Prospective Patient Registry for Radiation Oncology Techniques and Quality (GCC 1490)
Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
연구 개요
상세 설명
The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:
Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)
연구 유형
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21201
- Ummc Msgcc
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients who are 18 years old or older and scheduled to undergo any of the listed radiation treatment technologies at the University of Maryland Medical Center or one of its community sites as included in this protocol provided s/he consents to participate.
Exclusion Criteria:
- Patients who are incarcerated or in legal custody are not eligible for this study.
- Patients who are younger than 18 years, are cognitively impaired, or are otherwise unable to provide informed consent.
- Patients who are pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Radiation Therapy
Participants receiving one of the 11 listed therapy modalities.
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targeted radiation treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.
기간: 5 years
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Records will be assessed to identify per-patient numbers and grades of toxicities and adverse events resulting from radiation treatment for oncologic conditions as graded by treating physicians according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during the period of radiation treatment and at each regularly scheduled clinical follow-up appointment, for each of the 11 therapeutic modalities listed as interventions.
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments.
기간: 5 years
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Records will be assessed to identify numbers of patients with specific initial diagnoses (from approximately 100 International Statistical Classification of Diseases and Related Health Problems [ICD 9] malignant neoplasm diagnoses) who experience short- and long-term toxicities after any of the 11 therapeutic modalities listed as interventions.
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5 years
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Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments.
기간: 5 years
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Records will be assessed to identify numbers of men and women who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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Age differences in short- and long-term toxicities associated with specific radiation treatment modalities.
기간: 5 years
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Records will be assessed to identify numbers of men and women between the ages of 18-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and ≥90 years who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities.
기간: 5 years
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Records will be assessed for income (by patient home zip code per U.S. Internal Revenue statistics available at http://www.irs.gov/uac/SOI-Tax-Stats-Individual-Income-Tax-Statistics-ZIP-Code-Data-(SOI)) to identify income level differences and per-patient numbers/ types of CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: William Regine, MD, UMMC MSGCC Department of Radiation Oncology
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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Radiation Therapy에 대한 임상 시험
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Alpha Tau Medical LTD.모병
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Alpha Tau Medical LTD.모병
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