Uniform Noting for International Application of the Tumor-Stroma Ratio as an Easy Diagnostic Tool: Protocol for a Multicenter Prospective Cohort Study
Bibliographic record
Abstract
BACKGROUND: Colon cancer treatment is dependent on the stage at diagnosis. The current Tumor-Node-Metastasis (TNM) 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 undertreatment. We developed a new, easy-to-apply, practice-changing method to select colon cancer patients for adjuvant chemotherapy: the tumor-stroma ratio (TSR). The TSR distinguishes within stage II-III patients who will likely benefit from adjuvant chemotherapy and those who will not. OBJECTIVE: The aim of the study was to add, in addition to the TNM classification, the TSR to current routine pathology evaluation. Pathologists will be instructed for scoring the TSR in combination with a quality assessment program. An international multicenter study will validate the parameter prospectively. METHODS: The study is designed for future implementation of the TSR to the current TNM guidelines, using routinely Haematoxylin- and Eosin-stained tumor tissue sections. In part 1 of the study, an electronic learning (e-learning) module with a quality assessment program using the European Society of Pathology framework will be developed. This module will be used to assess the reliability and reproducibility of the TSR, conducted by national and international pathologists. Part 2 will involve the validation of the TSR in a prospective cohort of colon cancer p-stage II-III patients in a multicenter setting. In total, 1500 patients will be included. RESULTS: The results of part 1 will be expected in the first half of 2019. For part 2, the inclusion of patients in the prospective study, which started at the end of 2018, will take 3 years with an additional follow-up after another 3 years. CONCLUSIONS: The main endpoints of this study are as follows: in part 1, trained (international) pathologists who are able to reliably score the TSR, resulting in low intra- and interobserver variation; in part 2, confirmation of significant survival differences for patients with a stroma-high tumor versus patients with a stroma-low tumor. On the basis of these findings, a modification in current treatment guidelines will be suggested. TRIAL REGISTRATION: Netherlands Trial Register NTR7270; https://www.trialregister.nl/trial/7072. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13464.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".