Uniform Noting for International application of the Tumour-stroma ratio as Easy Diagnostic tool

Uniform Noting for International application of the Tumour-stroma ratio as Easy Diagnostic tool. Chemotherapy or not? Practice changing approach for the selection of patients for accurate chemotherapy treatment after colon cancer diagnosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23560

Enrollment

1172

Registered

2018-06-13

Start date

2018-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

colon cancer

Interventions

Since the TSR is determined on routine resection tissue used for conventional pathological clinical decision making, there is no additional intervention for the patient.

Eligibility

Inclusion criteria

Inclusion criteria: histologically proven colon carcinoma p-stage II or III age ≥ 18 years written informed consent

Exclusion criteria

Exclusion criteria: neo-adjuvant treatment no complete curative resection (not R0 resection)another malignancy within 10 years prior to the current colon carcinoma multiple synchronous colon tumours rectum tumours

Design outcomes

Primary

Measure	Time frame
1. Well trained (international) pathologists, having used the eLearning module, with low intra- and inter-observer variation. 2. Differences in Overall Survival (OS) and Disease Free Survival (DFS) between patients with a stroma-high tumour versus patients with a stroma-low tumour within each stage. Differences in response to current treatment regimens between patients with a stroma-high tumour versus patients with a stroma-low tumour.	—

Measure

Time frame

1. Well trained (international) pathologists, having used the eLearning module, with low intra- and inter-observer variation. 2. Differences in Overall Survival (OS) and Disease Free Survival (DFS) between patients with a stroma-high tumour versus patients with a stroma-low tumour within each stage. Differences in response to current treatment regimens between patients with a stroma-high tumour versus patients with a stroma-low tumour.

—

Secondary

Measure	Time frame
3. A fully automated image analysis for the determination of the TSR. 4. A written proposal with guidelines for a clinical trial using shared-decision-making.	—

Contacts

Public ContactA.G.H. Roodvoets

LUMC Datacenter, Dept. of Surgery, K6-R

datacenter@lumc.nl+31715263500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)