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Not yet recruitingNCT05881057Updated May 30, 2023

Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

An observational study in Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-30.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 75 Years
Sex
All
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Study summary

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.

Read the detailed description

This study intends to apply the intraoperative navigation system based on Surface-enhanced Raman Scatting (SERS) technology to detect the PH of lung tissue, and to evaluate the benign and malignant resection margins of lung tissue based on this. In order to clarify the discrimination mechanism, a multi-omics mass spectrometry platform is planned to study the internal small molecules and pathway changes. In addition, the patients were followed up for five years to explore the correlation between the prognosis of patients and the PH of lung tissues and lymph nodes, which could prove the clinical transformation value of this technology.

02

Conditions studied

  • Lung Cancer

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Keywords

  • surgical margin
  • PH
  • prognosis
  • mass-spectrometry
  • Surface-enhanced Raman Scatting (SERS)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 200 is close to the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-small cell lung cancer surgery patients in Shanghai Pulmonary Hospital

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall Survival(OS)

    Time from randomization to death (from any cause).

    Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months

  2. Recurrence free survival(RFS)

    The time from surgery to recurrence or the end of follow-up was defined.

    Time frame: From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 60 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • National 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. PubMed 21714641 ↗
  • Becker 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. PubMed 31162856 ↗
  • Pastorino 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. PubMed 31168572 ↗
  • Edwards 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. PubMed 31731014 ↗
  • Saji 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. PubMed 35461558 ↗
  • Suzuki K, Watanabe SI, Wakabayashi M, Saji H, Aokage K, Moriya Y, Yoshino I, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. A single-arm study of sublobar resection for ground-glass opacity dominant peripheral lung cancer. J Thorac Cardiovasc Surg. 2022 Jan;163(1):289-301.e2. doi: 10.1016/j.jtcvs.2020.09.146. Epub 2020 Nov 12. PubMed 33487427 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881057
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Responsible party
Yayi He (Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
May 30, 2023
Start date
Jun 2023 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
May 30, 2023

Study contacts

Yayi He, PHD,MD
Contact
doctorjael@qq.com
+86 021-65115006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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