Lung Adenocarcinoma, Stage INCT05830812
Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma, Stage I, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lung Adenocarcinoma, Stage I
- What is being tested?
- Invasiveness diagnosis
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2018 to December 2022, about 3000 patients with lung adenocarcinoma were enrolled in this retrospective study.
Who may be able to join
- CT examination within 3 months before surgery Patients with operable clinical stage I lung cancer No previous treatment in the lungs or any other organ
- ≥ 20 years and ≤ 80 years old Tumor less than 3cm in diameter on thin-slice (0.625-1 mm) CT images Lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis
Who cannot join
- Marked artifacts on CT images History of preoperative treatment Incomplete clinical information or DICOM images History of other malignant tumors Lung cancer associated with cystic airspaces
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xueyun Tan, MD, 13419692313 ext. 86, tanxueyun93@sina.com
About this study
Official title: Improving the Intraoperative Diagnosis Accuracy for Pre-invasive and Invasive Small-sized Lung Adenocarcinoma Node by Combining Multi-modal Information
The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.
- Conditions
- Lung Adenocarcinoma, Stage I
- Being tested
- Invasiveness diagnosis
- Keywords
- multi-modal information, lung adenocarcinoma, intraoperative diagnosis, invasiveness
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasiveness diagnosisDiagnostic test
To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.
| Study group | Role | What they receive |
|---|---|---|
| adenocarcinoma in situ | Adenocarcinoma in situ is defined as a small (≤3 cm) localized nodule with lepidic growth, mostly non-mucinous. Receives: Diagnostic Test: Invasiveness diagnosis | |
| minimally invasive adenocarcinoma | Minimally invasive adenocarcinoma defined as a small (≤3 cm) solitary adenocarcinoma with a predominantly lepidic pattern and ≤5 mm invasion in greatest dimension. Receives: Diagnostic Test: Invasiveness diagnosis | |
| invasive adenocarcinoma | Invasive adenocarcinoma is a malignant epithelial tumor with glandular differentiation, mucin production, or pneumocyte marker expression. The tumors show an acinar, papillary, micropapillary, lepidic, or solid growth pattern, with either mucin or pneumocyte marker expression. The invasive ademocarcinoma component should be present in at least one focus measuring >5mm in greatest dimension. Receives: Diagnostic Test: Invasiveness diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final pathology diagnosis of the paraffin section stained with HE
The final pathology diagnosis after resection
Measured: Immediately after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Adenocarcinoma, Stage IStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Yang Jin, PHD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830812
- Sponsor's protocol ID
- HXJY20220701
- Status last verified
- Sep 2024
- First submitted
- 24 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Intraoperative Diagnosis Accuracy for Pre-invasive and Invasive Small-sized Lung Adenocarcinoma Node by Combining Multi-modal Information
- ClinicalTrials.gov ID
- NCT05830812
- Acronym / sponsor ID
- HXJY20220701
- Conditions
- Lung Adenocarcinoma, Stage I
- Keywords
- multi-modal information, lung adenocarcinoma, intraoperative diagnosis, invasiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Apr 2023 (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.
The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adenocarcinoma in situ | – | Diagnostic Test: Invasiveness diagnosisAdenocarcinoma in situ is defined as a small (≤3 cm) localized nodule with lepidic growth, mostly non-mucinous. |
| minimally invasive adenocarcinoma | – | Diagnostic Test: Invasiveness diagnosisMinimally invasive adenocarcinoma defined as a small (≤3 cm) solitary adenocarcinoma with a predominantly lepidic pattern and ≤5 mm invasion in greatest dimension. |
| invasive adenocarcinoma | – | Diagnostic Test: Invasiveness diagnosisInvasive adenocarcinoma is a malignant epithelial tumor with glandular differentiation, mucin production, or pneumocyte marker expression. The tumors show an acinar, papillary, micropapillary, lepidic, or solid growth pattern, with either mucin or pneumocyte marker expression. The invasive ademocarcinoma component should be present in at least one focus measuring >5mm in greatest dimension. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2018 to December 2022, about 3000 patients with lung adenocarcinoma were enrolled in this retrospective study.
Key inclusion criteria (2 listed)
- CT examination within 3 months before surgery Patients with operable clinical stage I lung cancer No previous treatment in the lungs or any other organ
- ≥ 20 years and ≤ 80 years old Tumor less than 3cm in diameter on thin-slice (0.625-1 mm) CT images Lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis
Key exclusion criteria (1 listed)
- Marked artifacts on CT images History of preoperative treatment Incomplete clinical information or DICOM images History of other malignant tumors Lung cancer associated with cystic airspaces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasiveness diagnosisTo predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information. | Diagnostic test | adenocarcinoma in situ, invasive adenocarcinoma, minimally invasive adenocarcinoma |
Primary outcome
Final pathology diagnosis of the paraffin section stained with HE
Time frame: Immediately after operation
The final pathology diagnosis after resection
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Yang Jin, PHD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Lung Adenocarcinoma, Stage I, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 19 Sep 2024. 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 Xueyun Tan, MD (13419692313 ext. 86, tanxueyun93@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final pathology diagnosis of the paraffin section stained with HE (time frame: Immediately after operation). 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 19 Sep 2024.