Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors

NCT05921474 | Unknown

• 1 other identifier: SABR-DETECT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine if liquid biopsies from patients with stage I non-small cell lung cancer (NSCLC) can add to the diagnosis of a small lung cancer, or can better detect recurrent lung cancer compared to the standard of care procedures used for diagnosing this type of cancer. The main question\[s\] it aims to answer are:

• Primary Objective: 1\) To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer
• Secondary Objectives:
• To assess the impact of SABR on detection rates of ctDNA in patients undergoing SABR for early-stage lung tumors.
• To correlate positivity by blood-based cancer detection platforms and pre-treatment probability of malignancy using the Brock and Herder models.

Conditions

Non Small Cell Lung Cancer

Keywords

Early Stage Lung Cancer; Stage I/IIA; Tumor stage T1-T2b

Outcome Measures

Primary Outcomes (1)

• To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer.

  Percentage of patients with MRD detected prior to or at the time of radiological recurrence, with longitudinal monitoring of ctDNA

  End of study (approximately Dec 2023)

Secondary Outcomes (2)

• To assess the impact of SABR on detection rates of ctDNA in patients undergoing SABR for early-stage lung tumors.

  End of study (approximately Dec 2023)

• To correlate positivity by blood-based cancer detection platforms and pre-treatment probability of malignancy using the Brock and Herder models.

  End of study (approximately Dec 2023)

Study Arms (2)

Patients with Unbiopsied, Presumed Stage I/IIA NSCLC Undergoing SABR

The first cohort will be comprised of patients with suspected stage I/IIA NSCLC with plans to undergo curative SABR.

Patients with Stage I-IIA NSCLC Undergoing SABR

The second cohort will be comprised of patients with biopsy proven NSCLC, with clinically staged I/IIA disease with a plan to undergo definitive therapy with SABR.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Stage I/IIA Non-small cell lung cancer that will undergo Stereotactic Ablative Radiotherapy (SABR) for a solitary pulmonary nodule with tissue confirmation or those without tissue confirmation of malignancy.

You may qualify if:

• Age 18 years or older
• Willing to provide informed consent
• Undergoing SABR for a solitary pulmonary nodule (SPN) with tissue confirmation or those without tissue confirmation of malignancy, must have a pretreatment likelihood of malignancy of ≥ 60% using either the Herder or Brock models (60% probability was chosen to have a reasonable chance that there will indeed be cancer in the nodule; however, most patients are expected to have a pretreatment probability of \> 85%).
• Tumor stage T1-T2b (≤ 5 cm)
• No evidence of nodal or distant metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

You may not qualify if:

• Contraindications to radiotherapy
• Prior history of any invasive malignancy within 5 years, which might interfere with the interpretation of the ctDNA results. Non-melanoma skin cancer is allowed if under appropriate control.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (1)

• Verma S, Young S, Kennedy TAC, Carvalhana I, Black M, Baer K, Churchman E, Warner A, Allan AL, Izaguirre-Carbonell J, Dhani H, Louie AV, Palma DA, Breadner DA. Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors (SABR-DETECT). Clin Lung Cancer. 2024 Mar;25(2):e87-e91. doi: 10.1016/j.cllc.2023.11.013. Epub 2023 Dec 1.

  PMID: 38101984 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma will be collected for circulating tumor DNA (ctDNA) and cancer detection analysis at eight time-points. At each time-point, four 10 mL \[Paxgene circulating cell-free DNA (ccfDNA), Streck blood collection tube (BCT) or K2EDTA\] tubes will be drawn.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Breadner, MD

  519-685-8640

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Breadner, MD

CONTACT

519-685-8640; Daniel.Breadner@lhsc.on.ca

David Palma, MD

CONTACT

519-685-8500; David.Palma@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: June 27, 2023
• Study Start: April 3, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)