Lung CancerEarly Phase 1PORTNCT06979661
Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
A Early Phase 1 study testing Haystack™ ctDNA Assay in people with Lung Cancer and Non Small Cell Lung Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Primary Objective: Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer, Lung Cancer Recurrent
- What is being tested?
- Haystack™ ctDNA Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided signed informed consent for the trial
- Aged ≥18 years at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
- No active second cancers/malignancy
- Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible
- Willing and able to comply with all aspects of the protocol
- Standard of care therapy and methods as per institution and investigator discretion -
Who cannot join
- Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
- With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
- Have known active CNS metastases and/or carcinomatous meningitis.
- Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
- Have a history of interstitial lung disease.
- Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Salma Jabbour, MD, 732-235-2465, jabboursk@cinj.rutgers.edu
About this study
Official title: Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial
Primary Objective:
Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.
Read more
Secondary Objectives:
Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status
Exploratory Objective:
Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.
Read the detailed description
This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) who have undergone surgical resection. The study aims to assess whether ctDNA monitoring can effectively detect minimal residual disease (MRD) and improve post-surgical treatment strategies.
- Being tested
- Haystack™ ctDNA Assay
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haystack™ ctDNA AssayDiagnostic test
A personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and/or systemic therapy adjustments.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm - ctDNA-Guided Treatment | Experimental | This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions. Receives: Diagnostic Test: Haystack™ ctDNA Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.
Measured: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
Secondary outcomes (3)
Progression-Free Survival (PFS)
This outcome measures the time from surgery to disease progression or recurrence, as determined by imaging, clinical assessment, or rising ctDNA levels detected via the Haystack™ ctDNA assay.
Measured: Up to 3 years post-surgery
Overall Survival (OS)
The time from surgery to death from any cause. This will assess whether ctDNA-guided treatment impacts long-term survival outcomes in patients with Stage II-III NSCLC.
Measured: Up to 5 years post-surgery
Change in ctDNA Levels Over Time
Measures the change in ctDNA levels detected in serial blood draws, evaluating whether fluctuations correlate with treatment response, recurrence risk, or progression.
Measured: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Jabbour, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979661
- Sponsor's protocol ID
- 032411
- Acronym
- PORT
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial
- ClinicalTrials.gov ID
- NCT06979661
- Acronym / sponsor ID
- PORT / 032411
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 20 May 2025 (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.
Primary Objective:
Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.
Secondary Objectives:
Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status
Exploratory Objective:
Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.
Detailed description
This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) who have undergone surgical resection. The study aims to assess whether ctDNA monitoring can effectively detect minimal residual disease (MRD) and improve post-surgical treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm - ctDNA-Guided Treatment | Experimental | Diagnostic Test: Haystack™ ctDNA AssayThis single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have provided signed informed consent for the trial
- Aged ≥18 years at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
- No active second cancers/malignancy
Key exclusion criteria (6 listed)
- Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
- With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
- Have known active CNS metastases and/or carcinomatous meningitis.
- Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
- Have a history of interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haystack™ ctDNA AssayA personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and/or systemic therapy adjustments. | Diagnostic test | Single-Arm - ctDNA-Guided Treatment |
Primary outcome
Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
Time frame: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 3 years post-surgery
Overall Survival (OS)
Time frame: Up to 5 years post-surgery
Change in ctDNA Levels Over Time
Time frame: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Haystack™ ctDNA Assay in people with Lung Cancer and Non Small Cell Lung Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 May 2025. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Jabbour, MD (732-235-2465, jabbousk@cinj.rugers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Circulating Tumor DNA (ctDNA) Post-Surgery (time frame: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.