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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Area under ROC curve (AUC)

Area under the curve

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

Secondary outcomes

1

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 (%).

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

Other outcomes

Sponsors and contacts

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