Using frozen section pathology to guide surgery for lung adenocarcinoma
Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing Spread Through Air Space (STAS) of Lung Adenocarcinoma
This study is testing if using quick frozen tissue samples during lung surgery can help doctors make better decisions for patients with early-stage lung adenocarcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1063 (estimated) |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05794724 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of intraoperative frozen section pathology in diagnosing lung adenocarcinoma compared to post-operative paraffin embedded pathology. By confirming the concordance rate between these two diagnostic methods, the study seeks to enhance surgical decision-making for patients with early-stage lung adenocarcinoma. The focus is on patients with peripheral clinical T1N0M0 tumors who are eligible for surgical resection. The findings could potentially lead to more effective surgical treatments based on real-time pathology results.
Who should consider this trial
Good fit: Ideal candidates are patients with solitary or multiple lung lesions that are clinically staged as T1N0M0 and are eligible for surgical resection.
Not a fit: Patients with clinical stages other than T1N0M0 or those who have received prior cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and treatment precision for patients with early-stage lung adenocarcinoma.
How similar studies have performed: Other studies have shown promise in using intraoperative frozen section pathology for various cancers, suggesting potential success for this approach in lung adenocarcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who sign the informed consent form and are willing to complete the study according to the study protocol; * No previous history of cancer or pulmonary surgery; * Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan; * Peripheral clinical T1N0M0 patients that are eligible for surgery; * Non-small cell lung cancer is pathologically diagnosed before or at surgery; * No radiation therapy or chemotherapy before surgery. Exclusion Criteria: * Patients with clinical stages other than T1N0M0; * The lesion cannot be completely resected; * Previous history of cancer; * Patients having received radiation therapy or chemotherapy.
Where this trial is running
Shanghai, Shanghai
- Fudan University Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yue Zhao, M.D., Ph.D.
- Email: yuezhao97@outlook.com
- Phone: +86 18801735510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.