Non Small Cell Lung CancerSABR-DETECTNCT05921474
Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors
An observational study of Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
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:
Read more
- 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.
Study investigators will also assess the rate of detection for targetable mutations in this patient population, and to correlate ctDNA findings, in patients without tissue confirmed disease.
Blood samples from participants will collected at eight (8) time-points: before the participant's first radiation treatment, following their first treatment and then at their 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up visits.
Read the detailed description
This is a multi-institutional cohort study. The first cohort will be comprised of patients with suspected stage I/IIA NSCLC with plans to undergo curative 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.
Focused, or stereotactic, radiation therapy is a standard treatment for early-stage lung cancer when surgery is not possible due to comorbidities or when patient denies surgery and opts for radiation therapy. Many patients with early stage (1 or 2) disease often have treatment with radiation without a tissue biopsy, because of the risk associated with the procedure of tissue biopsy. If the chances of mass being spread to other organs are very high, the risk of treating a lesion with radiation without a biopsy is less than the risk of a biopsy. Unfortunately, many of these patients will have their cancer come back at the local site or at a new site (10-20% risk of recurrence at 1 year). At such time they need a tissue biopsy for diagnosis and biomarker testing to decide the best treatment options. The time to get a biopsy and complete results can take over a month.
Liquid biopsy is a type of test which isolates the cancer derived circulating DNA from blood. This DNA can be tested for mutations and other changes. This offers a chance to diagnose cancer patients in whom biopsy is not possible, or may provide the result faster or safer than a conventional biopsy. Additionally, liquid biopsies can detect mutations which can be used to guide treatment if cancer comes back (recurs); and treatment could be started without a biopsy or immediately after the biopsy before the results are available. It may also help detect a recurrence earlier compared to surveillance imaging.
This study, SABR-DETECT may answer these questions -
- Can the investigators detect a recurrence earlier with a liquid biopsy, compared to standard surveillance with CT scans?
- Can radiation increase the ability to diagnose cancer when the baseline liquid biopsy test is negative?
- Can liquid biopsy be used for diagnosis of lung cancer in patients when a tissue biopsy is not possible or the risks are too high?
Plasma will be collected for ctDNA and cancer detection analysis at eight time-points. At each time-point, four 10 mL (Paxgene ccfDNA, Streck BCT or K2EDTA) tubes will be drawn.
- Draw #1: prior to the first fraction of SABR, ideally on the same day as treatment (but before treatment delivery).
- Draw #2: this should be collected on the second day after the first fraction (± 24 hours if collection is not feasible on that day). For example, if the first treatment is on a Monday, the second collection should occur on a Wednesday, but may occur anytime between Tuesday and Thursday.
- Draws #3-8: at 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up, respectively.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Early Stage Lung Cancer, Stage I/IIA, Tumor stage T1-T2b
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- The percentage of patients with undetectable ctDNA at baseline who then develop detectable ctDNA after one fraction of SABR.
- Increase in variant allelic frequency (vAF) or quantifiable ctDNA (mutant molecules/mL of plasma) from baseline to post-treatment samples, in patients with detectable ctDNA at baseline.
Measured: 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.
Correlation between pre-treatment malignancy risk to the rate of ctDNA positivity
Measured: End of study (approximately Dec 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start3 Apr 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Breadner, MD, Principal investigator, 519-685-8640
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921474
- Sponsor's protocol ID
- SABR-DETECT
- Acronym
- SABR-DETECT
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38101984
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors
- ClinicalTrials.gov ID
- NCT05921474
- Acronym / sponsor ID
- SABR-DETECT / SABR-DETECT
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Early Stage Lung Cancer, Stage I/IIA, Tumor stage T1-T2b
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study investigators will also assess the rate of detection for targetable mutations in this patient population, and to correlate ctDNA findings, in patients without tissue confirmed disease.
Blood samples from participants will collected at eight (8) time-points: before the participant's first radiation treatment, following their first treatment and then at their 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up visits.
Detailed description
This is a multi-institutional cohort study. The first cohort will be comprised of patients with suspected stage I/IIA NSCLC with plans to undergo curative 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.
Focused, or stereotactic, radiation therapy is a standard treatment for early-stage lung cancer when surgery is not possible due to comorbidities or when patient denies surgery and opts for radiation therapy. Many patients with early stage (1 or 2) disease often have treatment with radiation without a tissue biopsy, because of the risk associated with the procedure of tissue biopsy. If the chances of mass being spread to other organs are very high, the risk of treating a lesion with radiation without a biopsy is less than the risk of a biopsy. Unfortunately, many of these patients will have their cancer come back at the local site or at a new site (10-20% risk of recurrence at 1 year). At such time they need a tissue biopsy for diagnosis and biomarker testing to decide the best treatment options. The time to get a biopsy and complete results can take over a month.
Liquid biopsy is a type of test which isolates the cancer derived circulating DNA from blood. This DNA can be tested for mutations and other changes. This offers a chance to diagnose cancer patients in whom biopsy is not possible, or may provide the result faster or safer than a conventional biopsy. Additionally, liquid biopsies can detect mutations which can be used to guide treatment if cancer comes back (recurs); and treatment could be started without a biopsy or immediately after the biopsy before the results are available. It may also help detect a recurrence earlier compared to surveillance imaging.
This study, SABR-DETECT may answer these questions -
- Can the investigators detect a recurrence earlier with a liquid biopsy, compared to standard surveillance with CT scans?
- Can radiation increase the ability to diagnose cancer when the baseline liquid biopsy test is negative?
- Can liquid biopsy be used for diagnosis of lung cancer in patients when a tissue biopsy is not possible or the risks are too high?
Plasma will be collected for ctDNA and cancer detection analysis at eight time-points. At each time-point, four 10 mL (Paxgene ccfDNA, Streck BCT or K2EDTA) tubes will be drawn.
- Draw #1: prior to the first fraction of SABR, ideally on the same day as treatment (but before treatment delivery).
- Draw #2: this should be collected on the second day after the first fraction (± 24 hours if collection is not feasible on that day). For example, if the first treatment is on a Monday, the second collection should occur on a Wednesday, but may occur anytime between Tuesday and Thursday.
- Draws #3-8: at 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer.
Time frame: End of study (approximately Dec 2023)
Percentage of patients with MRD detected prior to or at the time of radiological recurrence, with longitudinal monitoring of ctDNA
2 secondary outcomes
To assess the impact of SABR on detection rates of ctDNA in patients undergoing SABR for early-stage lung tumors.
Time frame: 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.
Time frame: End of study (approximately Dec 2023)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 38101984Verma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Breadner, MD principal investigator
519-685-8640
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Breadner, MD (519-685-8640, Daniel.Breadner@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer. (time frame: End of study (approximately Dec 2023)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.