Stage I Pulmonary AdenocarcinomaNCT04202614
Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma
An observational study of Stage I Pulmonary Adenocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Pulmonary Adenocarcinoma
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from pulmonary adenocarcinoma in stage I
Who may be able to join
- 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
Who cannot join
- primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Stage I Pulmonary Adenocarcinoma
- Medical subject headings
- Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start2 Dec 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stage I Pulmonary AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Carretta Angelo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202614
- Sponsor's protocol ID
- PET-TC Adenocarcinoma
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26352534Travis 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.
PubMed 26291008Tsutani 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.
PubMed 24551879
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04202614
- Acronym / sponsor ID
- PET-TC Adenocarcinoma
- Conditions
- Stage I Pulmonary Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from pulmonary adenocarcinoma in stage I
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET
Time frame: 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 26352534Khullar 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.
- Results publication: PubMed 26291008Travis 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.
- Results publication: PubMed 24551879Tsutani 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.
- Individual participant dataSharing planned: No
Related trials for Stage I Pulmonary Adenocarcinoma
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage I Pulmonary Adenocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.