No registrations found.
ID
Source
Brief title
Health condition
colon cancer; staging, stroma, tumor-stroma ratio
Sponsors and support
Stichting Fonds Oncologie Holland (SFOH)
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
There is increasing evidence that the tumour stroma plays an important role in the biological behavior of tumours, their growth, ability to metastasize, but also their response or resistance to anti-cancer drugs [1-4]. Tumours, that are rich in stroma behave in a more aggressive way compared to tumours that have little stroma.
The TSR parameter is based on the amount of stroma or fibrosis within the primary tumour and can be determined during routine pathology diagnostic assessment. Using the TSR, stage II/III stroma-high (high-risk) patients will be adequately registered for treatment with chemotherapy whereas for the (elderly) patient with stage III and stroma-low it can be further discussed if adjuvant therapy benefits. New guidelines for patient management will be developed and will have consequences for clinical patient management leading to a reduction in costs due to a better selection for adjuvant chemotherapy.
Study objective
The study goal is to add the TSR to current routine pathology diagnosis next to the TNM classification.
Study design
baseline / registration
surgery + pathology
3 year follow up for recurrence and survival
Intervention
Since the TSR is determined on routine resection tissue used for conventional pathological clinical decision making, there is no additional intervention for the patient.
A.G.H. Roodvoets
P.O.-box 9600
Leiden 2300 RC
The Netherlands
+31715263500
datacenter@lumc.nl
A.G.H. Roodvoets
P.O.-box 9600
Leiden 2300 RC
The Netherlands
+31715263500
datacenter@lumc.nl
Inclusion criteria
histologically proven colon carcinoma
p-stage II or III
age ≥ 18 years
written informed consent
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7072 |
NTR-old | NTR7270 |
Other | CME LUMC : KWF 10174 |