A Study Of Patients Undergoing Neoadjuvant Therapy For Resectable Non-small Cell Lung Cancer To Evaluate Perioperative Circulating Tumor DNA As A Prognostic Biomarker
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-007171
Sponsor Protocol Number: 22-007171
About this study
The purpose of this study is to determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
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:
- Patients who are 18-years of age or older.
- Patients with stage IIA-IIIB disease.
- Patients with a NSCLC deemed surgically resectable and medically operable by a qualified thoracic surgeon.
- Patients being treated with neoadjuvant cytotoxic, targeted or immunotherapy with or without radiotherapy.
Exclusion Criteria:
- Patients who do not have a complete preoperative staging evaluation including whole-body PET/CT scan, brain MRI, and mediastinal nodal staging (EBUS or mediastinoscopy).
Eligibility last updated 7/11/22. 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 |
Jacksonville, Fla.
Mayo Clinic principal investigator Ian Makey, M.D. |
Closed for enrollment |
Contact information:
Mauricia Buchanan
Contact Usbuchanan.mauricia@mayo.edu
|
More information
Publications
Publications are currently not available