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

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.

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Key information

Conditions

CRC (Colorectal Cancer) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer (Diagnosis) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Li Liang

CONTACT

[email protected]

+8615989146266

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Area under ROC curve (AUC)

Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

Area under the curve

Secondary outcomes

Specificity

Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Zhengyu Zhang

CONTACT

[email protected]

+8613837365993

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Nov 20, 2025
Registry last updated: Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting