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

NCT07239063 | Recruiting

• 1 other identifier: NFEC-2024-535
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CRC (Colorectal Cancer); Lung Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Area under ROC curve (AUC)

  Area under the curve

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

Secondary Outcomes (1)

• Specificity

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without DNA: Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang Li

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhengyu Zhang

CONTACT

+8613837365993; zzyusmu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)