ABCSG R07 Rectal Cancer Registry

NCT07780305 | Not Yet Recruiting

• 1 other identifier: ABCSG R07
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rectal Cancer; Adenocarcinoma of Rectum

Keywords

Rectal; cancer; registry; total neoadjuvant therapy; mismatch repair-deficient; locally advanced rectal cancer; Non-interventional study; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Treatment Responses (clinical standard therapy)

  Recording of treatment responses according to clinical standard therapy.

  At the time of surgery

Secondary Outcomes (15)

• Proportion of different TNT concepts used

  From therapy start to Surgery

• Proportion of participants using immunotherapy

  From therapy start to Surgery

• Proportion of participants using watch & wait therapy

  At surgery visit

• Proportion of the surgical techniques used

  At surgery

• Proportion of locoregional recurrences

  From therapy start until 3 years from re-staging or end of primary treatment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status

You may qualify if:

• 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

You may not qualify if:

• Distant metastases at primary diagnosis

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• Austrian Breast & Colorectal Cancer Study Group: lead

Study Sites (3)

LKH Salzburg-PMU, Univ. Klinik f. Innere Med III

Salzburg, State of Salzburg, 5020, Austria

Location

Ordensklinikum Linz - BHS

Linz, Upper Austria, 4010, Austria

Location

Kepler Universitätsklinikum Linz

Linz, Upper Austria, 4020, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood: whole blood or plasma * Tissue: FFPE

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms; Turcot syndrome; Adenocarcinoma

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Falk Roeder, Prof, MD

  Paracelsius Medical University Salzburg

  STUDY CHAIR

• Gudrun Piringer, MD, MSc

  Johannes Kepler University Linz

  STUDY CHAIR

• Lukas Weiss, Prof, MD

  Paracelsius Medical University Salzburg

  STUDY CHAIR

Central Study Contacts

Miriam Muehlburger, MSc

CONTACT

+43 1 4089230; miriam.muehlburger@abcsg.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (3)