ABCSG R07 Rectal Cancer Registry (ABCSG R07 RCR)
ABCSG R07 Rectal Cancer Registry (RCR) - Multicenter Retrospective and Prospective Analysis of Patients With Localized, Non-metastatic Rectal Cancer in Austria
In Austria, patients with rectal cancer that has not spread to other parts of the body are typically treated with either total neoadjuvant therapy (TNT) or immunotherapy, depending on their microsatellite status (DNA repair capacity).
However, treatment can vary considerably between hospitals in Austria. These differences may include the type and duration of treatment, as well as the active ingredients used. There are currently no clear recommendations on which exact treatment is best for each specific case.
The aim of this observational study is to collect information on the different treatments used in Austria for patients with localized rectal cancer and to document the outcomes of these treatments.
Only information and samples collected as part of the patients' routine care will be used for the study. Participation in the study will not change or affect the treatment chosen by the treating physician.
연구 개요
상태
상태
상세 설명
The purpose of this observational study is to establish a registry for locally advanced rectal adenocarcinoma. This registry will document the treatment regimens of participants receiving "total neoadjuvant therapy (TNT)" as well as those with dMMR/MSI-H disease.
The ABCSG R07 Rectal Cancer Registry (RCR) study will provide real-world data that reflect the current therapeutic landscape for participants. Participants who are either treated with "total neoadjuvant therapy (TNT)" or those with dMMR/ MSI-H disease, as well as their response to the respective standard therapy, will be documented.
"Total neoadjuvant therapy (TNT)" is the preferred treatment option for locally advanced rectal adenocarcinoma; however, treatment is carried out according to a different TNT protocol at each hospital or institute.
Since the observational study does not interfere with the course of treatment, neither additional health risks nor any individual benefit from participation in the non-interventional study is to be expected.
This study is being conducted at approx. 6 study sites in Austria, and a total of about 600 participants (retrospective and prospective) will take part. The treating physician selects the treatment/therapy that she/he considers most appropriate for the participant. In the retrospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between June 2020 (or June 2005 for dMMR/MSI-H cohort,) and start of this non-interventional study will be enrolled.
In the prospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between start of this non-interventional study and three years thereafter will be enrolled.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Miriam Muehlburger, MSc
- 전화번호: +43 1 4089230
- 이메일: miriam.muehlburger@abcsg.at
연구 장소
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State of Salzburg
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Salzburg, State of Salzburg, 오스트리아, 5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
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연락하다:
- Lukas Weiss, MD, Prof.
- 전화번호: 25804 +4357255
- 이메일: lu.weiss@salk.at
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수석 연구원:
- Lukas Weiss, MD, Prof.
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Upper Austria
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Linz, Upper Austria, 오스트리아, 4020
- Kepler Universitätsklinikum Linz
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연락하다:
- Gudrun Piringer, MD, MSc
- 전화번호: +435768082
- 이메일: gudrun.piringer@kepleruniklinikum.at
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수석 연구원:
- Gudrun Piringer, MD, MSc
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Linz, Upper Austria, 오스트리아, 4010
- Ordensklinikum Linz - BHS
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연락하다:
- Holger Rumpold, MD, Head
- 전화번호: 4230 +43-732-7677
- 이메일: holger.rumpold@bhs.at
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수석 연구원:
- Holger Rumpold, MD, Head
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Female and male participants with age >= 18 years
- Signed informed consent obtained prior to registration of the participant.
- Localized rectal cancer treated with TNT or localized, non-metastatic dMMR/MSI-H rectal cancer, irrespective of treatment
Exclusion Criteria:
- Distant metastases at primary diagnosis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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Retrospective part
Participants treated between June 2020 and study start.
For dMMR/MSI-H cohort: treated between June 2005 until study start
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Prospective part
Participants treated between study start and three years after study start
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Treatment Responses (clinical standard therapy)
기간: At the time of surgery
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Recording of treatment responses according to clinical standard therapy.
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At the time of surgery
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of different TNT concepts used
기간: From therapy start to Surgery
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Treatment details
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From therapy start to Surgery
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Proportion of participants using immunotherapy
기간: From therapy start to Surgery
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From therapy start to Surgery
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Proportion of participants using watch & wait therapy
기간: At surgery visit
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At surgery visit
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Proportion of the surgical techniques used
기간: At surgery
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At surgery
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Proportion of locoregional recurrences
기간: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Proportion of the participants with distant metastases
기간: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Event-free survival (EFS)
기간: From therapy start until 3 years from re-staging or end of primary treatment
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EFS includes locoregional event, distant metastasis and death
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From therapy start until 3 years from re-staging or end of primary treatment
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TME-free survival in watch & wait group
기간: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Overall survival (OS)
기간: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Locoregional event-free survival (LREFS)
기간: From therapy start until 3 years from re-staging or end of primary treatment
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locoregional progression, recurrence, regrowth or death
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From therapy start until 3 years from re-staging or end of primary treatment
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Distant metastasis-free survival (DMFS)
기간: From therapy start until 3 years from re-staging or end of primary treatment
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From therapy start until 3 years from re-staging or end of primary treatment
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Charlson Comorbidity Index (CCI) Score prior to any treatment start
기간: Baseline
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Baseline
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ECOG performance status at diagnosis
기간: Diagnosis
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Diagnosis
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Proportion of resection rates
기간: Surgery
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Surgery
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Treatment adherence
기간: From therapy start until surgery
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From therapy start until surgery
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
- 연구 의자: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
- 연구 의자: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ABCSG R07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Key-coded personal information from this study may also be used for future ((non-)commercial, (inter-)national) scientific research projects & statistics, provided the respective project is conducted in compliance with accepted standards of ethical principles; the responsible researcher(s)/statistician(s) has/have no legal means to de-identify any key-coded personal information.
Data will be shared with other collaborating academic groups/people & companies who work with the Sponsors, including but not limited to ECs, ABCSG (holder of clin. database) and will be used for study purposes mentioned in protocol & future scientific research projects, if agreed by the participant.
Any data transfer will comply with respective applicable data law/regulations. The use of data must be defined in advance in a project description & SAP, approved by ABCSG Board/Committee and will be transferred acc. with resp. Data Transfer Agreement.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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