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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07239063

Enrollment

1000

Registered

2025-11-20

Start date

2024-10-01

Completion date

2027-12-01

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRC (Colorectal Cancer), Lung Cancer (Diagnosis)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Specificity	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 (%).

Countries

China

Contacts

CONTACTZhengyu Zhang

zzyusmu@163.com+8613837365993

STUDY_DIRECTORLiang Li

Nanfang Hospital, Southern Medical University

Outcome results