Application of SERS Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy

Lung Cancer Clinical Trial

Official title:

Application of Surface-enhanced Raman Scatting (SERS) Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885815
• Other study ID #: 2023HY0520
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, PHD,MD
• Phone: +86 021-65115006
• Email: doctorjael[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to explore the application of surface-enhanced Raman scattering (SERS) technology and specific PD-L1 detection fluorescent probes in the clinical diagnosis and prognosis of lung cancer immunotherapy, and further promote the rapid diagnosis of lung cancer and the precision of tumor immunotherapy.

Description:

The aim of this study is to explore the application of surface-enhanced Raman scattering (SERS) system in the diagnosis of benign and malignant lung cancer biopsy, and to promote the rapid diagnosis of lung cancer. In addition, the correlation between tumor PH value, PD-L1 expression detected by fluorescent probes and the efficacy and prognosis of immunotherapy was explored. Based on this, the immunotherapy efficacy and prognosis prediction models based on patients' clinical information, PD-L1 expression by immunohistochemistry, PD-L1 expression by fluorescent probes and PH value detected by SERS were constructed to promote the precision of tumor immunotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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. Fiberoptic bronchoscopy or percutaneous lung biopsy was performed.

4. Lung cancer cannot be surgically resected.

5. At least one measurable target lesion assessed by IRRC according to RECIST 1.1. Patients must provide eligible tumor tissue for PD-L1 expression and PH measurement. (7) Related laboratory tests suggested that chemotherapy and immunotherapy could be tolerated.

Exclusion Criteria:

1. NSCLC patients with unclear diagnosis;

2. Patients with contraindications to chemotherapy or immunotherapy.

3. Contraindication of lung biopsy.

4. Other active malignant tumors within the past year or at the same time.

5. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.

6. According to the investigator's judgment, the patient had other factors that may lead to early termination of the study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

References & Publications (7)

Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, Eder JP, Balmanoukian AS, Aggarwal C, Horn L, Patnaik A, Gubens M, Ramalingam SS, Felip E, Goldman JW, Scalzo C, Jensen E, Kush DA, Hui R. Five-Year Overall Survival for Patients With Advanc — View Citation

Hirsch FR, Scagliotti GV, Mulshine JL, Kwon R, Curran WJ Jr, Wu YL, Paz-Ares L. Lung cancer: current therapies and new targeted treatments. Lancet. 2017 Jan 21;389(10066):299-311. doi: 10.1016/S0140-6736(16)30958-8. Epub 2016 Aug 27. — View Citation

Kazdal D, Endris V, Allgauer M, Kriegsmann M, Leichsenring J, Volckmar AL, Harms A, Kirchner M, Kriegsmann K, Neumann O, Brandt R, Talla SB, Rempel E, Ploeger C, von Winterfeld M, Christopoulos P, Merino DM, Stewart M, Allen J, Bischoff H, Meister M, Mule — View Citation

Kennedy LB, Salama AKS. A review of cancer immunotherapy toxicity. CA Cancer J Clin. 2020 Mar;70(2):86-104. doi: 10.3322/caac.21596. Epub 2020 Jan 16. — View Citation

Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20. — View Citation

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy — View Citation

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Time from randomization to death (from any cause).	From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months
Primary	PFS	The time between the initiation of randomization and the occurrence (any aspect) of tumor progression or death (from any cause).	From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months
Primary	ORR	Refers to the proportion of subjects whose tumors shrink by a certain amount and remain for a certain period of time, including those with CR+PR.	The proportion of patients who achieved a 30%(usual) reduction in tumor volume while maintaining the minimum required duration was calculated at month 24 of the study
Primary	DOR	Is the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever occurs first.	The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study.