NCT03336658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9.3 years

First QC Date

November 6, 2017

Last Update Submit

April 28, 2026

Conditions

CRC

Outcome Measures

Primary Outcomes (1)

  • correlation of ITB based calculated N stage with real N stage in CRC - patients

    24 months

Secondary Outcomes (1)

  • correlation of ITB based calculated DFS with real DFS in CRC - patients

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stages I to IV colorectal cancer

You may qualify if:

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

You may not qualify if:

  • No consent
  • \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of visceral surgery and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor buds will be Immunohistochemically stained with a pancytokeratin marker

Study Officials

  • Beat Schnüriger, PD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 8, 2017

Study Start

October 1, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)