Clinical trial · Observational

Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer

NCT05881057CI-TRIAL-00066764not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study aims to explore the application of Surface-enhanced Raman Scatting (SERS) technology in lung cancer surgery and clarify its mechanism through multi-omics mass spectrometry platform, and then further prove the clinical transformation value of this technology.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Overall Survival(OS)
timeFrame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
description
Time from randomization to death (from any cause).
measure
Recurrence free survival(RFS)
timeFrame
From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 60 months
description
The time from surgery to recurrence or the end of follow-up was defined.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Voluntary participation in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures.
2. Male or female aged 18-75 years or more when signing ICF.
3. Extended tumor resection was performed to remove the lung tumor tissue, and the resection margin was ≥2cm from the tumor margin.
4. The effective measured diameter of all the lung tissues to be measured was greater than 0.5cm.
5. The patient had not received previous systemic therapy for cancer.

Exclusion Criteria:

1. Unresectable lung cancer patients.
2. Patients had received previous systemic therapy for lung cancer.
3. Patients with other active malignant tumors within the past year or at the same time.
4. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
5. According to the investigator's judgment, the patient had other factors that may lead to the early termination of the study.

References

Publications (6)

RESULTNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
RESULTBecker N, Motsch E, Trotter A, Heussel CP, Dienemann H, Schnabel PA, Kauczor HU, Maldonado SG, Miller AB, Kaaks R, Delorme S. Lung cancer mortality reduction by LDCT screening-Results from the randomized German LUSI trial. Int J Cancer. 2020 Mar 15;146(6):1503-1513. doi: 10.1002/ijc.32486. Epub 2019 Jun 20. PMID 31162856
RESULTPastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Oct 1;30(10):1672. doi: 10.1093/annonc/mdz169. No abstract available. PMID 31168572
RESULTEdwards JG, Chansky K, Van Schil P, Nicholson AG, Boubia S, Brambilla E, Donington J, Galateau-Salle F, Hoffmann H, Infante M, Marino M, Marom EM, Nakajima J, Ostrowski M, Travis WD, Tsao MS, Yatabe Y, Giroux DJ, Shemanski L, Crowley J, Krasnik M, Asamura H, Rami-Porta R; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Board Members, and Participating Institutions. The IASLC Lung Cancer Staging Project: Analysis of Resection Margin Status and Proposals for Residual Tumor Descriptors for Non-Small Cell Lung Cancer. J Thorac Oncol. 2020 Mar;15(3):344-359. doi: 10.1016/j.jtho.2019.10.019. Epub 2019 Nov 13. PMID 31731014
RESULTSaji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.