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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Miriam Muehlburger, MSc
- Номер телефона: +43 1 4089230
- Электронная почта: miriam.muehlburger@abcsg.at
Места учебы
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State of Salzburg
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Salzburg, State of Salzburg, Австрия, 5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
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Контакт:
- Lukas Weiss, MD, Prof.
- Номер телефона: 25804 +4357255
- Электронная почта: lu.weiss@salk.at
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Главный следователь:
- Lukas Weiss, MD, Prof.
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Upper Austria
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Linz, Upper Austria, Австрия, 4020
- Kepler Universitätsklinikum Linz
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Контакт:
- Gudrun Piringer, MD, MSc
- Номер телефона: +435768082
- Электронная почта: gudrun.piringer@kepleruniklinikum.at
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Главный следователь:
- Gudrun Piringer, MD, MSc
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Linz, Upper Austria, Австрия, 4010
- Ordensklinikum Linz - BHS
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Контакт:
- Holger Rumpold, MD, Head
- Номер телефона: 4230 +43-732-7677
- Электронная почта: holger.rumpold@bhs.at
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Главный следователь:
- Holger Rumpold, MD, Head
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Treatment Responses (clinical standard therapy)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Proportion of different TNT concepts used
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At surgery visit
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At surgery visit
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Proportion of the surgical techniques used
Временное ограничение: At surgery
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At surgery
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Proportion of locoregional recurrences
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: Baseline
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Baseline
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ECOG performance status at diagnosis
Временное ограничение: Diagnosis
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Diagnosis
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Proportion of resection rates
Временное ограничение: Surgery
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Surgery
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Treatment adherence
Временное ограничение: From therapy start until surgery
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From therapy start until surgery
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Соавторы и исследователи
Соавторы
Следователи
- Учебный стул: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
- Учебный стул: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
- Учебный стул: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Кишечные заболевания
- Новообразования по гистологическому типу
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Колоректальные новообразования
- Новообразования кишечника
- Заболевания прямой кишки
- Новообразования железистые и эпителиальные
- Карцинома
- Новообразования
- Новообразования прямой кишки
- Аденокарцинома
- Синдром турко
Другие идентификационные номера исследования
- ABCSG R07
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .