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Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer

Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03336658
Acronym
ITB
Enrollment
150
Registered
2017-11-08
Start date
2015-10-01
Completion date
2024-12-31
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRC

Brief summary

All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.

Interventions

None listed

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients with newly diagnosed stages I and IV colorectal cancer (CRC) * Age ≥ 18 years * Written Informed Consent

Exclusion criteria

* No consent * \< 18 years

Design outcomes

Primary

MeasureTime frame
correlation of ITB based calculated N stage with real N stage in CRC - patients24 months

Secondary

MeasureTime frame
correlation of ITB based calculated DFS with real DFS in CRC - patients24 months

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORBeat Schnüriger, PD

Insel Gruppe AG, University Hospital Bern

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026