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NCT06979661Not yet recruitingEarly phase 1

Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy

Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial

Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
25 (estimated)
First submitted
13 May 2025
Start date
1 Jun 2025
Primary completion date
1 Jun 2028
Lead sponsor
Rutgers, The State University of New Jersey
Diseases
Lung cancer
NCT number
NCT06979661

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 25
  • From 1 Jun 2025 to the primary completion date, 1 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent

Other illness

  • With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
  • Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
  • Have a history of interstitial lung disease.

Lab values

  • 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. -

Other

  • Have known active CNS metastases and/or carcinomatous meningitis.

Who the study is looking for

  • 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 -

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rutgers Cancer Institute
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.