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

Validation of a High-Throughput, Large-Format, Tissue-Specific Preprocessing Protocol 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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer (Diagnosis); CRC (Colorectal Cancer)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Zhengyu Zhang; Phone Number: +8613837365993; Email: zzyusmu@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Li Liang; Phone Number: +8615989146266; Email: lli@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with a confirmed pathological diagnosis of colorectal cancer or lung cancer. Eligible participants include adults who have undergone diagnostic biopsy or surgical resection yielding tumor tissue available for analysis. Clinical data and corresponding tumor specimens (including H&E slides, paraffin blocks, and discarded ex vivo tissue) will be collected. All cases were prospectively collected from Nanfang Hospital, Southern Medical University.

Description

Inclusion Criteria:

1. Patients who have been pathologically diagnosed as having lung cancer or colorectal cancer.
2. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under ROC curve (AUC)	Area under the curve	Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	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 (%).	Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Study Director: Liang Li, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Colorectal Neoplasms; Disease
• Other Study ID Numbers: NFEC-2024-535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No