Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution.

A second blood draw will be collected at 12 months.

Subject with suspicion of lung cancer will provide a blood sample.

Diagnostic information will be collected to confirm the final diagnosis.

Subject has pathologically confirmed lung cancer and is treatment naïve.

Subject will be enrolled and provide a blood sample.

Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.

Blood Sample Collection

Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.

Subjects participating in the study will have blood drawn at enrollment.

Laura Strong

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.

Residual blood samples may be used for further analysis and future research. Samples may be stored for up to 20 years. These blood samples will be de-identified.

Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form, and clinical study report will also be shared.

Screening subjects to find the appropriate methylation sites for the detection of lung cancer

Exact Sciences Corporation

Symptoms and General Pathology

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Liquid Biopsy in Lung Cancer

Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer

To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

To compared the accuracy of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

Samsung Medical Center

Associate Professor

Participants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy

Participants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration.

Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

Device for performing biopsy via electromagnetic navigation bronchoscopy

Yeon Wook Kim, MD., PhD

This randomized crossover study aimed to compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions with electromagnetic navigation bronchoscopy, and whether combination of the two methods (needle and forceps) can provide additive benefit for diagnosis.

This randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (ENB)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions.

The investigators designed this study to prospectively enroll patients with lung lesions that warrant histologic diagnosis and are feasible for undergoing electromagnetic bronchoscopy under moderate sedation. Participants will be randomized to two groups. One group will receive ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-centered group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-centered group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy, radial endobronchial sonography. All participants will be followed up for up to 1 year to confirm the final diagnosis.

The primary endpoint is the diagnostic yield of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with individual modalities. Diagnostic yield was defined as the proportion of participants in whom the biopsy resulted in a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management

Secondary endpoints include sensitivity for malignancy based on 12-month follow-up results to determine true or false negatives, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.

The attending physician and patient will be blinded to the randomized group and which method of biopsy (needle or forceps) would be performed first. The pulmonologist performing the ENB procedure will be informed just before the start of the procedure which group the patient is affiliated to.

Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy

Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy

The proportion of pathologic results that leads to a specific malignant or benign diagnosis

(\[True positive + True negative\]/All biopsied performed)

Total duration and time per sampling for needle and forceps biopsy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer	NCT03633006	Lung Cancer (Di...	Blood Sample Co... Blood Sample Co... Blood Sample Co...	35 Years -	Exact Sciences Corporation
Liquid Biopsy in Lung Cancer	NCT03479099	Lung Cancer (Di... Circulating Tum...		18 Years - 80 Years	Samsung Medical Center
Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy	NCT05110131	Lung Cancer Lung Cancer (Di...	Device for perf...	18 Years -	Seoul National University Bundang Hospital
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer	NCT03633006	Lung Cancer (Di...	Blood Sample Co... Blood Sample Co... Blood Sample Co...	35 Years -	Exact Sciences Corporation

Spots Global Cancer Trial Database for lung cancer (diagnosis)