A Study to Examine Biomarkers From Lung and Blood Samples in Participants With Suspected Lung Cancer (NCT04951154) | Clinical Trial Compass
CompletedNot Applicable
A Study to Examine Biomarkers From Lung and Blood Samples in Participants With Suspected Lung Cancer
United States33 participantsStarted 2022-03-28
Plain-language summary
The purpose of this study is to assess spontaneous residual viable tumor cells (RVT) in the surgically resected tumor (Non-small cell lung cancer \[NSCLC\]).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of one or more radiographically identified 1-5 centimeter (cm) solid or sub-solid lung lesions with at least a 1 cm solid component highly suspicious for lung cancer and requiring bronchoscopic diagnosis, with a computed tomography (CT) scan or other cross-sectional imaging (example, CT-positron emission tomography \[PET\]) within 28 days of the intended bronchoscopy
* Deemed by the investigator(s), including thoracic surgeon, to be a suitable candidate for surgical resection with curative intent, following review of participant information which may include past medical history, medications, pulmonary function testing, and CT scan
* Able to tolerate general anesthesia and a diagnostic bronchoscopy, as assessed by the investigator
* Each participant (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and the procedures required for the study and are willing to participate in the study
Exclusion Criteria:
* Participants who are currently receiving, have received within the last 6 months, or plan to receive any systemic treatment for their presumed lung cancer between Screening visit and the last blood sample collection at Week 6 visit
* Participants who have previously received radiation therapy to the lung (example, radiation therapy to chest wall, such as for breast cancer is allowed)
* Participants who are currently receiving systemic steroids o…
What they're measuring
1
Percent of Residual Viable Tumor Cells (% RVT) at the Time of Non-small Cell Lung Cancer (NSCLC) Resection