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Recruiting NCT07239063

Validation of High-Throughput Large-Format Tissue Preprocessing for Lung and Colorectal Cancer

Observational CRC (Colorectal Cancer) Lung Cancer (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: CRC (Colorectal Cancer), Lung Cancer (Diagnosis). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Validation of a High-Throughput, Large-Format, Tissue-Specific Preprocessing Protocol for Lung and Colorectal Cancer

Overview

This project aims to employ a sample preprocessing system in conjunction with three-dimensional imaging techniques to generate morphologically more complete, high-resolution datasets for lung and colorectal cancers. Building on systematic experimental optimization of the preprocessing system, the investigators will establish tissue-clearing workflows and transparency assessment criteria specifically for lung and colorectal cancer specimens, and develop and validate an efficient 3D immunofluorescent iterative staining protocol adapted for these tumor types to achieve robust three-dimensional imaging. Successful implementation of this project will enable an in-depth characterization of the spatial morphological features of lung and colorectal cancer pathology, facilitate identification of more effective and precise interventional strategies, and ultimately contribute to improved overall survival for cancer patients. Additionally, the resulting datasets will support prospective validation of two-dimensional pathological models.

Primary outcome measures

  • Area under ROC curve (AUC) [Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained]
Secondary outcome measures (1)
  • Specificity [Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained]

Eligibility criteria

Inclusion criteria

  • Patients who have been pathologically diagnosed as having lung cancer or colorectal cancer.
  • Patients with complete clinical data and tumor tissue materials, including H\&E slides, paraffin blocks, and discarded ex vivo specimens.

Exclusion criteria

1.Patients with missing data or specimens not meeting quality control requirements for analysis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT07239063 · NFEC-2024-535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗