CRC (Colorectal Cancer)NCT07239063
Validation of High-Throughput Large-Format Tissue Preprocessing for Lung and Colorectal Cancer
An observational study of CRC (Colorectal Cancer) and Lung Cancer (Diagnosis), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CRC (Colorectal Cancer), Lung Cancer (Diagnosis)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Li Liang, +8615989146266, lli@smu.edu.cn
About this study
Official title: 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.
- Conditions
- CRC (Colorectal Cancer), Lung Cancer (Diagnosis)
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under ROC curve (AUC)
Area under the curve
Measured: 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 (%).
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang Li, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239063
- Sponsor's protocol ID
- NFEC-2024-535
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a High-Throughput, Large-Format, Tissue-Specific Preprocessing Protocol for Lung and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07239063
- Acronym / sponsor ID
- NFEC-2024-535
- Conditions
- CRC (Colorectal Cancer), Lung Cancer (Diagnosis)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under ROC curve (AUC)
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Area under the curve
1 secondary outcome
Specificity
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Li study director
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC (Colorectal Cancer) and Lung Cancer (Diagnosis), run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengyu Zhang (+8613837365993, zzyusmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under ROC curve (AUC) (time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.