- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202614
Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma
February 9, 2021 updated by: Prof. Carretta Angelo, IRCCS San Raffaele
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milan, Italy, 20132
- IRCCS San Raffaele
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients suffering from pulmonary adenocarcinoma in stage I
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET
Time Frame: 12 months
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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
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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: 10.1378/chest.13-1094.
- 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 Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
December 12, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET-TC Adenocarcinoma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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