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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Miriam Muehlburger, MSc
- Numer telefonu: +43 1 4089230
- E-mail: miriam.muehlburger@abcsg.at
Lokalizacje studiów
-
-
State of Salzburg
-
Salzburg, State of Salzburg, Austria, 5020
- LKH Salzburg-PMU, Univ. Klinik f. Innere Med III
-
Kontakt:
- Lukas Weiss, MD, Prof.
- Numer telefonu: 25804 +4357255
- E-mail: lu.weiss@salk.at
-
Główny śledczy:
- Lukas Weiss, MD, Prof.
-
-
Upper Austria
-
Linz, Upper Austria, Austria, 4020
- Kepler Universitätsklinikum Linz
-
Kontakt:
- Gudrun Piringer, MD, MSc
- Numer telefonu: +435768082
- E-mail: gudrun.piringer@kepleruniklinikum.at
-
Główny śledczy:
- Gudrun Piringer, MD, MSc
-
Linz, Upper Austria, Austria, 4010
- Ordensklinikum Linz - BHS
-
Kontakt:
- Holger Rumpold, MD, Head
- Numer telefonu: 4230 +43-732-7677
- E-mail: holger.rumpold@bhs.at
-
Główny śledczy:
- Holger Rumpold, MD, Head
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Retrospective part
Participants treated between June 2020 and study start.
For dMMR/MSI-H cohort: treated between June 2005 until study start
|
|
Prospective part
Participants treated between study start and three years after study start
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Treatment Responses (clinical standard therapy)
Ramy czasowe: At the time of surgery
|
Recording of treatment responses according to clinical standard therapy.
|
At the time of surgery
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of different TNT concepts used
Ramy czasowe: From therapy start to Surgery
|
Treatment details
|
From therapy start to Surgery
|
|
Proportion of participants using immunotherapy
Ramy czasowe: From therapy start to Surgery
|
From therapy start to Surgery
|
|
|
Proportion of participants using watch & wait therapy
Ramy czasowe: At surgery visit
|
At surgery visit
|
|
|
Proportion of the surgical techniques used
Ramy czasowe: At surgery
|
At surgery
|
|
|
Proportion of locoregional recurrences
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
|
Proportion of the participants with distant metastases
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
|
Event-free survival (EFS)
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
EFS includes locoregional event, distant metastasis and death
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
TME-free survival in watch & wait group
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
|
Overall survival (OS)
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
|
Locoregional event-free survival (LREFS)
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
locoregional progression, recurrence, regrowth or death
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
Distant metastasis-free survival (DMFS)
Ramy czasowe: From therapy start until 3 years from re-staging or end of primary treatment
|
From therapy start until 3 years from re-staging or end of primary treatment
|
|
|
Charlson Comorbidity Index (CCI) Score prior to any treatment start
Ramy czasowe: Baseline
|
Baseline
|
|
|
ECOG performance status at diagnosis
Ramy czasowe: Diagnosis
|
Diagnosis
|
|
|
Proportion of resection rates
Ramy czasowe: Surgery
|
Surgery
|
|
|
Treatment adherence
Ramy czasowe: From therapy start until surgery
|
From therapy start until surgery
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Krzesło do nauki: Falk Roeder, Prof, MD, Paracelsius Medical University Salzburg
- Krzesło do nauki: Gudrun Piringer, MD, MSc, Johannes Kepler University Linz
- Krzesło do nauki: Lukas Weiss, Prof, MD, Paracelsius Medical University Salzburg
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Choroby jelit
- Nowotwory według typu histologicznego
- Nowotwory przewodu pokarmowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby przewodu pokarmowego
- Nowotwory jelita grubego
- Nowotwory jelit
- Choroby odbytu
- Nowotwory gruczołowe i nabłonkowe
- Rak
- Nowotwory
- Nowotwory odbytnicy
- Rak gruczołowy
- Zespół Turcota
Inne numery identyfikacyjne badania
- ABCSG R07
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .