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

NCT05885815 | Unknown

• 1 other identifier: 2023HY0520
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Cancer

Keywords

SERS; probes; biopsy; immunotherapy; prognosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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.

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Biopsy patients in Shanghai Pulmonary Hospital.

You may qualify if:

• 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.
• Male or female aged 18-75 years or more when signing ICF.
• Fiberoptic bronchoscopy or percutaneous lung biopsy was performed.
• Lung cancer cannot be surgically resected.
• 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.

You may not qualify if:

• NSCLC patients with unclear diagnosis;
• Patients with contraindications to chemotherapy or immunotherapy.
• Contraindication of lung biopsy.
• Other active malignant tumors within the past year or at the same time.
• The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
• According to the investigator's judgment, the patient had other factors that may lead to early termination of the study.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Related Publications (7)

• 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.

  PMID: 31944278 RESULT

• 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.

  PMID: 25605845 RESULT

• 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.

  PMID: 33433946 RESULT

• 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.

  PMID: 27574741 RESULT

• 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 Advanced Non-Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. J Clin Oncol. 2019 Oct 1;37(28):2518-2527. doi: 10.1200/JCO.19.00934. Epub 2019 Jun 2.

  PMID: 31154919 RESULT

• 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 for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.

  PMID: 33872070 RESULT

• 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, Muley T, Herth F, Penzel R, Warth A, Winter H, Frohling S, Peters S, Swanton C, Thomas M, Schirmacher P, Budczies J, Stenzinger A. Spatial and Temporal Heterogeneity of Panel-Based Tumor Mutational Burden in Pulmonary Adenocarcinoma: Separating Biology From Technical Artifacts. J Thorac Oncol. 2019 Nov;14(11):1935-1947. doi: 10.1016/j.jtho.2019.07.006. Epub 2019 Jul 23.

  PMID: 31349062 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yayi He, PHD,MD

CONTACT

+86 021-65115006; doctorjael@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share