Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment

October 11, 2023 updated by: Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
The precise diagnosis and treatment of lung cancer is not only a major national strategic need but also an urgent demand from the general public. The "three stages" of precise diagnosis and treatment of lung cancer include early diagnosis, effective treatment, and precise evaluation. Currently, invasive methods are mainly used in these three stages of clinical practice. The non-invasive molecular diagnosis of early-stage lung cancer and the molecular evaluation of treatment efficacy are critical core issues in lung cancer clinical diagnosis and treatment. In response to this problem, this project aims to use exhaled breath as a sample to develop a scientific instrument with independent intellectual property rights, which integrates early-stage diagnosis of lung cancer and evaluation of treatment efficacy. We will also conduct related application research to meet the needs of the public and contribute to the health of the entire population.

Study Overview

Status

Not yet recruiting

Conditions

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. Voluntarily participate in the clinical study; fully understand and be informed about this study, and sign the informed consent form (ICF); willing to comply with and have the ability to complete all trial procedures.
  2. Male or female participants aged 18-75 (inclusive) at the time of signing the ICF.
  3. The case group included patients diagnosed with lung cancer, including early-stage and advanced-stage patients; the control group consisted of healthy individuals without a history of lung cancer or related respiratory diseases.
  4. At least one measurable target lesion evaluated according to RECIST 1.1 criteria by the Institutional Review and Research Committee (IRRC).
  5. Patients provide eligible tumor tissue for histopathological testing as required.
  6. Relevant laboratory tests indicate tolerance to chemotherapy and immunotherapy.

Exclusion Criteria:

  1. Patients with unclear diagnosis of lung cancer.
  2. Patients with contraindications to chemotherapy or immunotherapy.
  3. Patients with contraindications to lung tissue examination.
  4. Patients with other respiratory diseases within the year or concurrent respiratory system diseases (such as chronic obstructive pulmonary disease, bronchial asthma, etc.).
  5. Patients with other active malignant tumors within the year or concurrently.
  6. Patients with severe heart disease and patients with other severe diseases (such as liver dysfunction, renal dysfunction, etc.).
  7. Patients known to have a history of psychiatric drug abuse or drug addiction; patients with a history of alcohol abuse.
  8. Based on the investigator's judgment, patients have other factors that may lead to premature termination of this 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)

November 7, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022tjdxsy048

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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