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

May 31, 2023 updated by: Yayi He, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Biopsy patients in Shanghai Pulmonary Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months
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
Time Frame: From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months
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
Time Frame: 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
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
Time Frame: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 20, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023HY0520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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