Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 23, 2019
Open Peer Review Period: Jan 28, 2019 - Feb 11, 2019
Date Accepted: May 14, 2019
(closed for review but you can still tweet)
Uniform Noting for International application of the Tumour-stroma ratio as Easy Diagnostic tool: study protocol
ABSTRACT
Background:
Colon cancer treatment is dependent on stage at diagnosis. The current TNM (Tumour-Node-Metastasis) staging for the selection of patients for adjuvant chemotherapy needs additional prognostic and predictive biomarkers. Better decision-making for chemotherapy will result in reducing over- and under-treatment. We developed a new, easy to apply, practice-changing method to select colon cancer patients for adjuvant (chemo)therapy: the tumour-stroma ratio (TSR). The TSR distinguishes within stage II-III patients who will likely benefit of adjuvant (chemo)therapy and from those who will not.
Objective:
The study goal is to add the TSR to current routine pathology evaluation in addition to the TNM classification. Pathologists will be instructed for scoring the TSR in combination with a quality assessment program. An international multicentre study will validate the parameter prospectively.
Methods:
The study prepares for implementation of the TSR to current TNM guidelines, using routinely Haematoxylin and Eosin stained tumour tissue sections. Part 1. An E-learning module with a quality assessment program in the framework of the European Society of Pathology will be developed. This module will be used to assess the reliability and reproducibility of TSR, conducted by national and international pathologists. Part 2. Validation of the TSR in a prospective cohort of colon cancer pathological stage II-III patients in a multicentre setting. In total 1500 patients will be included.
Results:
The results of part 1 will be expected first half of 2019. For part 2, the inclusion was started end 2018 and will take 3 years, with an additional follow-up of 3 years.
Conclusions:
The main endpoints of this study are: Part 1. Instructed (international) pathologists who are able to reliably score TSR, resulting in low intra- and inter-observer variation. Part 2. Confirmation of significant survival differences for patients with a stroma-high tumour versus patients with a stroma-low tumour. Based on these findings modification in current treatment guidelines will be suggested. Clinical Trial: The Netherlands Trial Registry (NTR 7270). http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7270
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