Fact CheckerSign in

NCT05838053Recruiting

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study

Source: ClinicalTrials.gov · Last updated 27 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive by intraoperative frozen sections.

Status (registry)
Recruiting
Study type
Observational
Enrollment
446 (estimated)
First submitted
20 Apr 2023
Start date
20 Aug 2019
Primary completion date
30 Apr 2028
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Diseases
Lung cancer
NCT number
NCT05838053

What you commit to

  • Study type: Observational
  • Planned participants: 446
  • From 20 Aug 2019 to the primary completion date, 30 Apr 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

  • Patients concomitant with other malignant tumors;
  • Patients had prior chemotherapy, radiotherapy or molecular targeted therapy for this malignancy.

Other illness

  • Evidence revealed locally advanced or metastatic disease;
  • History of severe heart disease, heart failure, myocardial infarction within the past 6 months.

Lab values

  • Patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) over 3 times the normal upper limit, Cr over the normal upper limit).

Other

  • The tumor is close to the hilum, which cannot perform segmentectomy ;
  • Patients suspected of lymph node positive by preoperative examination, including CT scans and mediastinal lymph node biopsy;
  • Intraoperative exploration revealed accidental pleural dissemination.
  • The patients who were not suitable for inclusion by researchers' evaluation.

Who the study is looking for

  • Tumor size ≤ 2 cm;
  • Solitary tumor and located in the outer third of the lung field;
  • Preoperative CT indicated that the nodules were single nodules or Concomitant nodules was less than minimal invasive adenocarcinoma;
  • Intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary and solid patterns positive (\>5%);
  • Confirmation of R0 status by intraoperative frozen section analysis;
  • Pulmonary function could withstand both segmentectomy and lobectomy (FEV1 \> 1.5 L or FEV1% ≥ 60%);
  • Sufficient organ function;
  • Performance status of 0,1 or 2;
  • Written informed consent.

Age in the registry: 20 years to 79 years · Sex: All · Accepts 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
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
YangpuChinaRecruiting

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