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Lung Neoplasms clinical trials

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NCT ID: NCT06419114 Recruiting - Lung Neoplasm Clinical Trials

Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions

OCTGTBIPPL
Start date: March 1, 2024
Phase:
Study type: Observational

In this prospective analysis, investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital. The procedures utilized a novel approach combining OCT with R-EBUS for guidance. Eligibility for participation was determined based on established guidelines for the application of diagnostic flexible bronchoscopy in adults. The admission criteria of this study were as followed: (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant. R-EBUS and OCT In this study, all procedures were conducted using a standardized flexible bronchoscopy (Olympus, Japan) featuring an outer diameter of 4.2mm. R-EBUS system (Olympus, Japan) incorporated an ultra-thin radial ultrasonic probe (Olympus UM-S20-17S), which measures merely 1.4mm in diameter. The OCT (Yongshida Medical Technology, Guangdong, China) probe is a cylindrical catheter, 1.7mm in diameter and 150cm in length. Placing the probe through the working channel of bronchoscope for real time dynamic scanning of lesions. Research Process In this study, the entirety of the procedures was performed by the same respiratory physician with 5 years of experience in respiratory endoscopic diagnosis and treatment, including preoperative evaluation, preparation, lesion localization and biopsy. The respiratory physician had examined the bilateral airways with flexible bronchoscopy after the completion of preoperative anesthesia and found no lesions. The subsequent step involved the precise placement of the OCT probe, guided by prior CT scan results. This stage was critical for marking the lesion, determining its nature (benign or malignant), and, in cases of malignancy, identifying its pathological classification. In instances where the OCT failed to identify any lesion, the R-EBUS was employed to facilitate lesion localization and biopsy. Conversely, when PPLs was detected via OCT, R-EBUS was additionally utilized to corroborate the PPLs localization and to assist in completing the biopsy procedure. For cases where OCT localization failed, R-EBUS would be used. After successful confirmation with R-EBUS, an attempt was made again to insert the OCT probe and completed biopsy. Rapid On-Site Evaluation (ROSE) was employed for the assessment of biopsy specimens. A total of five specimens were collected from each lesion and subjected to ROSE. In scenarios where ROSE provided a definitive diagnosis, no additional biopsies were deemed necessary. Conversely, in instances where ROSE yielded non-definitive results, further biopsy samples were obtained. All biopsy specimens were preserved in 10% formalin, preparing them for detailed histopathological analysis. The ultimate pathological diagnoses were determined based on the reports issued by the pathology department. In this study, the demographics of all patients were documented, including age, gender, and smoking history. Additionally, detailed clinical parameters, such as the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time of OCT and the number of specimens, were systematically recorded. investigators also conducted extensive follow-up to track histopathological outcomes, whether from surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure. All the patients were followed up by telephone or outpatient service on the 1st and 3rd day after the procedure, and adverse events were recorded. All individuals underwent general anesthesia and were fitted with a laryngeal mask.

NCT ID: NCT06418412 Recruiting - Clinical trials for Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer

A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC

Start date: March 15, 2024
Phase:
Study type: Observational

There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies. This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients.

NCT ID: NCT06412172 Recruiting - Clinical trials for Recurrent Respiratory Papillomatosis

The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)

Start date: April 15, 2024
Phase:
Study type: Observational

Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. The investigators hypothesize that by understanding the biology of RRP and the failed host immune responses against HPV, novel and rational therapies can be developed. This study will examine the genetic and immunologic alterations found in these rare tumors and distant metastatic involved sites (such as the lung) in patients diagnosed with RRP.

NCT ID: NCT06410716 Recruiting - Lung Cancer Clinical Trials

Comparing Valve-regulated Pleural Drainage to Traditional Closed Chest Tube Drainage

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

Thoracic drainage is an important adjunctive treatment following thoracic surgery, primarily aimed at removing postoperative blood, air, and exudate from the thoracic cavity. It helps maintain negative pressure in the thoracic cavity, promotes full lung expansion, and prevents pulmonary complications, especially atelectasis. Traditional closed thoracic drainage methods have many limitations. Dry valve-regulated pleural drainage system overcome these limitations. Preliminary studies have shown that they offer advantages such as high safety, ease of operation, and reduced nursing burden. The investigators plan to conduct a real-world randomized controlled study comparing the clinical efficacy of dry valve-regulated pleural drainage system with traditional water-sealed drainage systems, both of which are commonly used in clinical practice. The goal of this study is to provide solid evidence based on evidence-based medicine for the optimal practice of thoracic drainage, further optimize post-thoracic surgery drainage treatment protocols, enhance the quality and efficiency of patient care, and provide scientific evidence for the development or updating of relevant clinical guidelines.

NCT ID: NCT06410300 Recruiting - Lung Cancer Clinical Trials

Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

Start date: April 19, 2024
Phase:
Study type: Observational

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

NCT ID: NCT06406673 Recruiting - Clinical trials for Extensive Small Cell Lung Cancer

A Phase II Clinical Study of Cadonilimab in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer

Start date: October 16, 2023
Phase: Phase 2
Study type: Interventional

Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis. Approximately 75% of SCLC patients present with extensive-stage disease at the time of diagnosis, which is classically defined as a disease that cannot be encompassed by a single radiation field. Before the era of immunotherapy, the standard first-line therapy for ES-SCLC was platinum-based chemotherapy with etoposide; Once complete remission (CR) or partial remission (PR) was achieved after chemotherapy, consolidative thoracic radiation was recommended. Despite this standard treatment, the median overall survival (OS) of ES-SCLC is about 8-11 months, which has not changed for about 40 years. Combining concurrent radiotherapy of the thorax and immunochemotherapy may have a synergistic effect. Besides, for patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. With the most recent approval of EP plus a programmed death ligand 1(PD-L1) inhibitor, there are now more therapeutic options for managing ES-SCLC.The best second-line therapy after combination of chemo-immunotherapy is not well defined, as many second-line therapies were studied only after use of EP. However, second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP (with or without an immunotherapy), lurbinectedin, and topotecan. Therefore, we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC. We present a safety profile and a final analysis of ORR. In this single-center phase 2 trial, Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase). Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity. The primary endpoints was objective response rate (ORR); the second endpoints were progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and treatment-emergent adverse event (TEAE) .

NCT ID: NCT06406660 Recruiting - Clinical trials for Small Cell Lung Cancer

Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer

Start date: April 16, 2024
Phase: N/A
Study type: Interventional

This study plans to enroll 20 patients with recurrent small cell lung cancer. Patient-derived Organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

NCT ID: NCT06406608 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Patient-derived Organoid Drug Sensitivity Guided Treatment for Drug-resistant Recurrent Non-Small Cell Lung Cancer

Start date: April 16, 2024
Phase: N/A
Study type: Interventional

This study aims to enroll non-small cell lung cancer patients who have undergone at least two rounds of standard treatment for drug resistance/recurrence. Patient-derived Organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

NCT ID: NCT06402981 Recruiting - Liver Injury Clinical Trials

A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1/PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients

Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this observational study is to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury. The main questions it aims to answer are: - Exploring risk factors for liver injury. - Constructing a Predictive Model for the Occurrence of Liver Injury in PD-1/PD-L1 Inhibitor-Related Liver Injury. - Improving immunotherapy protocols for lung cancer patients.

NCT ID: NCT06391749 Recruiting - Cancer, Breast Clinical Trials

Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)

K-ACCELERATE
Start date: May 2024
Phase:
Study type: Observational

To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE. The study aims to recruit 1,000 participants who develop symptoms and signs specific to the top five common cancer types including breast, colorectal, gastric, liver and lung cancer. Primary objective: Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations. Secondary objectives: Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures.