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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04202614
Other study ID # PET-TC Adenocarcinoma
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2, 2019
Est. completion date January 31, 2020

Study information

Verified date February 2021
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The clinical and derived data from the preoperative computed axial tomography (CT) and Positron Emission Tomography (PET) of patients with pathological stage I pulmonary adenocarcinoma will be analyzed retrospectively, classified according to the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma, subjected to surgical treatment in our Operating Unit between August 2006 and July 2011. A follow-up will be performed on the patients enrolled in the study up to the date of death, and in any case no later than October 31, 2019


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients suffering from pulmonary adenocarcinoma in stage I underwent CT, PET and surgical treatment with radical intent, at San Raffale Hospital (thoracic surgery) between August 2006 and July 2011 Exclusion Criteria: - primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.

Study Design


Locations

Country Name City State
Italy IRCCS San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Khullar OV, Liu Y, Gillespie T, Higgins KA, Ramalingam S, Lipscomb J, Fernandez FG. Survival After Sublobar Resection versus Lobectomy for Clinical Stage IA Lung Cancer: An Analysis from the National Cancer Data Base. J Thorac Oncol. 2015 Nov;10(11):1625-33. doi: 10.1097/JTO.0000000000000664. — View Citation

Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organizati — View Citation

Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET classify patients with pulmonary adenocarcinoma in stage I (retrospective cases) based on the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma using clinical data and derived from preoperative CT and PET 12 months