Clinical Trial 23397

• Overview

  Study Title:

  Surgical Drain Fluid for Detection of Molecular Residual Disease (MRD) in Patients with Non-Small Cell Lung Cancer

  Objective:

  To investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with NSCLC

• Inclusion Criteria

  Key Inclusion Criteria:
  • COHORTS 1 AND 2: Non-small cell lung cancer
  • Male or female who is 18 years or older
  • Currently diagnosed with a NSCLC
  • Scheduled or will be scheduled for primary surgical resection with curative intent, with use of post-surgical drain
  • The participant is cognitively able to consent to participate in the study
  • The participant is healthy enough for blood draws and sample collection (at the discretion of the investigator)
  • COHORTS 3 AND 4: Healthy Controls/Comparators
  • Male or female who is 18 years or older
  • The participant is cognitively able to consent to participate in the study
  • The participant is healthy enough for blood draws and sample collection (at the discretion of the investigator)
  • The patient has no history of cancer diagnosis
  • Is scheduled to undergo a non-malignancy and non-infectious related surgical procedure, for example penetrating chest trauma, non-malignant pneumothorax, benign pleural effusion drainage, cardiac surgeries requiring chest tube placement which result in the use of surgical drain placements similar to those in cohorts 1 and 2

• Exclusion Criteria

  Key Exclusion Criteria:
  • COHORTS 1 AND 2: Non-small cell lung cancer
  • Participant does not meet all the inclusion criteria
  • Subject deemed not fit to participate at the investigator's discretion
  • Pulmonary carcinoid tumors (well-differentiated neuroendocrine tumors)
  • Participant has a history of previous cancer diagnosis, other than: non-melanomatous localized cutaneous malignancies (e.g., SCC, BCC); non-metastatic prostate cancer; and non-metastatic well differentiated thyroid cancers within the last 5 years
  • COHORTS 3 AND 4: Healthy Controls/Comparators
  • Participant does not meet all inclusion criteria
  • Subject deemed not fit to participate at the investigator's discretion
  • Participant undergoing surgery for infectious etiology

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