Surgical Drain Fluid for Detection of Molecular Residual Disease in Patients With Non-small Cell Lung Cancers

Overview

About this study

The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 a blood draw and sample collection (at the discretion of the Investigator).
  • The patient has no history of a 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: 

COHORTS 1 and 2: Non-small cell lung cancer

  • Participant does not meet all inclusion criteria.
  • Subject deemed not fit to participate at the Investigator’s discretion.
  • Pulmonary carcinoid tumors (well-differentiated neuroendocrine tumors).
  • Neoadjuvant therapy (chemotherapy, radiation therapy, immunotherapy, or combinations).
  • Participant has a history of a 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.  

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/4/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Luis Tapias Vargas, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20573875

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