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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Miriam Muehlburger, MSc
- 電話番号：+43 1 4089230
- メール：miriam.muehlburger@abcsg.at
研究場所
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State of Salzburg
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Salzburg、State of Salzburg、オーストリア、5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
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コンタクト：
- Lukas Weiss, MD, Prof.
- 電話番号：25804 +4357255
- メール：lu.weiss@salk.at
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主任研究者：
- Lukas Weiss, MD, Prof.
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Upper Austria
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Linz、Upper Austria、オーストリア、4020
- Kepler Universitätsklinikum Linz
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コンタクト：
- Gudrun Piringer, MD, MSc
- 電話番号：+435768082
- メール：gudrun.piringer@kepleruniklinikum.at
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主任研究者：
- Gudrun Piringer, MD, MSc
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Linz、Upper Austria、オーストリア、4010
- Ordensklinikum Linz - BHS
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コンタクト：
- Holger Rumpold, MD, Head
- 電話番号：4230 +43-732-7677
- メール：holger.rumpold@bhs.at
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主任研究者：
- Holger Rumpold, MD, Head
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Responses (clinical standard therapy)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of different TNT concepts used
時間枠：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
時間枠：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
時間枠：At surgery visit
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At surgery visit
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Proportion of the surgical techniques used
時間枠：At surgery
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At surgery
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Proportion of locoregional recurrences
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Baseline
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Baseline
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ECOG performance status at diagnosis
時間枠：Diagnosis
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Diagnosis
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Proportion of resection rates
時間枠：Surgery
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Surgery
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Treatment adherence
時間枠：From therapy start until surgery
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From therapy start until surgery
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協力者と研究者
協力者
捜査官
- スタディチェア：Falk Roeder, Prof, MD、Paracelsius Medical University Salzburg
- スタディチェア：Gudrun Piringer, MD, MSc、Johannes Kepler University Linz
- スタディチェア：Lukas Weiss, Prof, MD、Paracelsius Medical University Salzburg
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ABCSG R07
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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米国FDA規制医薬品の研究
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