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NCT06262386Recruiting

Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial

Utilizing Perioperative Variation Trends of Circulating Tumor Cells and Tumor Pathological Characteristics as a Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial

Source: ClinicalTrials.gov · Last updated 16 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates. In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse. The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
358 (estimated)
First submitted
22 Sept 2023
Start date
1 Aug 2023
Primary completion date
31 Jul 2028
Lead sponsor
Chang Gung Memorial Hospital
Diseases
Lung cancer
NCT number
NCT06262386

What you commit to

  • Study type: Interventional
  • Planned participants: 358
  • From 1 Aug 2023 to the primary completion date, 31 Jul 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.

Other

  • Pathologic stage greater than stage 3b or 4
  • Pathologic stage less than stage 1a1
  • Could not complete treatment course
  • Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance

Who the study is looking for

  • Patients who presented with resectable disease ( Clinical stage 1a to 3a)
  • Patients who received tumor resection

Age in the registry: 20 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
Ching-Yang Wu
Coordinator of this site? Confirm its status
Taoyuan CityTaiwanRecruiting

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