Carcinoma, Non-Small-Cell LungNCT02519062
Role of FDG PET, Immune and Hypoxic Marker in NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Dec 2018
- 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: We will recruit a maximum number of 130 NSCLC patients operated radically (stage I-III) at our institution during 2010-2014, of which are available clinical and instrumental data and surgical tumor specimen.
Who may be able to join
- Diagnosis of NSCLC (Stage I-III)
- FDG PET before surgery
Who cannot join
- Absence of tumor specimen
- No clinical data
- FDG-PET can not be evaluated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FDG-PET, Marker Immunologici ed Ipossici in Pazienti Affetti da Carcinoma Polmonare Non a Piccole Cellule in Stadio I-III Sottoposti a Chirurgia Radicale
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.
Read the detailed description
This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with NSCLC treated with surgery with radical intent at our center.
We will review FDG-PET acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (IHC). These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- No intervention
- Keywords
- Carcinoma, Non-Small-Cell Lung, FDG PET, hypoxia markers, immune markers
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a retrospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with non-small cell lung cancer undergoing surgery with hypoxia expression and tumor immune cell infiltration.
Measured: Baseline SUVmax up to 1 month before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egesta Lopci, MD, Principal investigator, Humanitas Clinical and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519062
- Sponsor's protocol ID
- 1332
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2015
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopci E, Grassi I, Chiti A, Nanni C, Cicoria G, Toschi L, Fonti C, Lodi F, Mattioli S, Fanti S. PET radiopharmaceuticals for imaging of tumor hypoxia: a review of the evidence. Am J Nucl Med Mol Imaging. 2014 Jun 7;4(4):365-84. eCollection 2014.
PubMed 24982822Saintigny P, Burger JA. Recent advances in non-small cell lung cancer biology and clinical management. Discov Med. 2012 Apr;13(71):287-97.
PubMed 22541616Vaupel P, Mayer A. Hypoxia in cancer: significance and impact on clinical outcome. Cancer Metastasis Rev. 2007 Jun;26(2):225-39. doi: 10.1007/s10555-007-9055-1.
PubMed 17440684Lopci E, Toschi L, Grizzi F, Rahal D, Olivari L, Castino GF, Marchetti S, Cortese N, Qehajaj D, Pistillo D, Alloisio M, Roncalli M, Allavena P, Santoro A, Marchesi F, Chiti A. Correlation of metabolic information on FDG-PET with tissue expression of immune markers in patients with non-small cell lung cancer (NSCLC) who are candidates for upfront surgery. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1954-61. doi: 10.1007/s00259-016-3425-2. Epub 2016 Jun 1.
PubMed 27251642Castello A, Grizzi F, Toschi L, Rossi S, Rahal D, Marchesi F, Russo C, Finocchiaro G, Lopci E. Tumor heterogeneity, hypoxia, and immune markers in surgically resected non-small-cell lung cancer. Nucl Med Commun. 2018 Jul;39(7):636-644. doi: 10.1097/MNM.0000000000000832.
PubMed 29608508Grizzi F, Castello A, Qehajaj D, Toschi L, Rossi S, Pistillo D, Paleari V, Veronesi G, Novellis P, Monterisi S, Mineri R, Rahal D, Lopci E. Independent expression of circulating and tissue levels of PD-L1: correlation of clusters with tumor metabolism and outcome in patients with non-small cell lung cancer. Cancer Immunol Immunother. 2019 Sep;68(9):1537-1545. doi: 10.1007/s00262-019-02387-9. Epub 2019 Sep 3.
PubMed 31482306Grizzi F, Castello A, Qehajaj D, Russo C, Lopci E. The Complexity and Fractal Geometry of Nuclear Medicine Images. Mol Imaging Biol. 2019 Jun;21(3):401-409. doi: 10.1007/s11307-018-1236-5.
PubMed 30003453
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG-PET, Marker Immunologici ed Ipossici in Pazienti Affetti da Carcinoma Polmonare Non a Piccole Cellule in Stadio I-III Sottoposti a Chirurgia Radicale
- ClinicalTrials.gov ID
- NCT02519062
- Acronym / sponsor ID
- 1332
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, FDG PET, hypoxia markers, immune markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Aug 2015 (estimated)
- 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.
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.
Detailed description
This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with NSCLC treated with surgery with radical intent at our center.
We will review FDG-PET acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (IHC). These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.
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
- We will recruit a maximum number of 130 NSCLC patients operated radically (stage I-III) at our institution during 2010-2014, of which are available clinical and instrumental data and surgical tumor specimen.
Key inclusion criteria (2 listed)
- Diagnosis of NSCLC (Stage I-III)
- FDG PET before surgery
Key exclusion criteria (3 listed)
- Absence of tumor specimen
- No clinical data
- FDG-PET can not be evaluated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a retrospective study | Other | – |
Primary outcome
Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with non-small cell lung cancer undergoing surgery with hypoxia expression and tumor immune cell infiltration.
Time frame: Baseline SUVmax up to 1 month before surgery.
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 1 Oct 2020.
- Background: PubMed 24982822Lopci E, Grassi I, Chiti A, Nanni C, Cicoria G, Toschi L, Fonti C, Lodi F, Mattioli S, Fanti S. PET radiopharmaceuticals for imaging of tumor hypoxia: a review of the evidence. Am J Nucl Med Mol Imaging. 2014 Jun 7;4(4):365-84. eCollection 2014.
- Background: PubMed 22541616Saintigny P, Burger JA. Recent advances in non-small cell lung cancer biology and clinical management. Discov Med. 2012 Apr;13(71):287-97.
- Background: PubMed 17440684Vaupel P, Mayer A. Hypoxia in cancer: significance and impact on clinical outcome. Cancer Metastasis Rev. 2007 Jun;26(2):225-39. doi: 10.1007/s10555-007-9055-1.
- Background: PubMed 27251642Lopci E, Toschi L, Grizzi F, Rahal D, Olivari L, Castino GF, Marchetti S, Cortese N, Qehajaj D, Pistillo D, Alloisio M, Roncalli M, Allavena P, Santoro A, Marchesi F, Chiti A. Correlation of metabolic information on FDG-PET with tissue expression of immune markers in patients with non-small cell lung cancer (NSCLC) who are candidates for upfront surgery. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1954-61. doi: 10.1007/s00259-016-3425-2. Epub 2016 Jun 1.
- Background: PubMed 29608508Castello A, Grizzi F, Toschi L, Rossi S, Rahal D, Marchesi F, Russo C, Finocchiaro G, Lopci E. Tumor heterogeneity, hypoxia, and immune markers in surgically resected non-small-cell lung cancer. Nucl Med Commun. 2018 Jul;39(7):636-644. doi: 10.1097/MNM.0000000000000832.
- Background: PubMed 31482306Grizzi F, Castello A, Qehajaj D, Toschi L, Rossi S, Pistillo D, Paleari V, Veronesi G, Novellis P, Monterisi S, Mineri R, Rahal D, Lopci E. Independent expression of circulating and tissue levels of PD-L1: correlation of clusters with tumor metabolism and outcome in patients with non-small cell lung cancer. Cancer Immunol Immunother. 2019 Sep;68(9):1537-1545. doi: 10.1007/s00262-019-02387-9. Epub 2019 Sep 3.
- Background: PubMed 30003453Grizzi F, Castello A, Qehajaj D, Russo C, Lopci E. The Complexity and Fractal Geometry of Nuclear Medicine Images. Mol Imaging Biol. 2019 Jun;21(3):401-409. doi: 10.1007/s11307-018-1236-5.
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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.
Egesta Lopci, MD principal investigator
Humanitas Clinical and Research Hospital
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 Carcinoma, Non-Small-Cell Lung, run by Istituto Clinico Humanitas 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 2 inclusion and 3 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 1 Oct 2020. 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?
Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with non-small cell lung cancer undergoing surgery with hypoxia expression and tumor immune cell infiltration. (time frame: Baseline SUVmax up to 1 month before surgery.). 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 NCT02519062, which also lists 7 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 1 Oct 2020.