Lung CancerCLEARLYNCT04323579
Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.
An observational study of Lung Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2018to 1 Jul 2021
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population should have the following inclusion criteria: Inclusion Criteria: - Age ≥ 55 years old and exposure to smoking more than 30 packsyear; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%). - Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study. - Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Who may be able to join
- Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Who cannot join
- Previous diagnosis of lung cancer.
- Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
- Performing a chest CT scan in the last 18 months.
- Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Federica Cioffi, 0282247371, federica.cioffi@humanitas.it
About this study
CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and radiomic signature, as complementary to assist early detection of lung cancer by low dose computed tomography-LDCT, using bioinformatics techniques; (b) assess the prognostic role of CTCs including the role of cells epithelial mesenchymal transition (EMT) and (c) standardize a method for genomic analysis of CTCs for early detection of treatment resistance.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort of stage I-II lung cancer patients | A prospective cohort of stage I-II lung cancer patients (N=80) candidates to surgery at Humanitas, and 40 controls with benign nodules. | |
| retrospective screening cohort of 50 patients | A retrospective screening cohort of 50 patients with screened lung cancer at MUG. | |
| prospective screening cohort of 30 patients | A prospective screening cohort of 30 patients with screened lung cancer and 100 matched negative controls enrolled at Humanitas cohort of 1000 participants (expected annual rate 1.5%). | |
| retrospective screening cohort from the NELSON study | A retrospective screening cohort from the NELSON study. | |
| Prospective cohort of stage IV lung cancer patients | A Prospective cohort of stage IV lung cancer patients (N=30) candidate to systemic therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the role of a bio-radiomic protocol as complementary tool to assist early detection of lung cancer by LDCT
CTC analysis will be performed using fresh plasma samples. Blood collection will be obtained for each lung cancer patient before and after surgery and once for controls. 45- and 16-miRNA signatures will be analyzed on plasma samples of the retrospective cohort (150 lung cancer patients and 120 matched controls). We will perform the exosome antigens analysis in the retrospective cohort. We will validate the 8-protein signature in the retrospective cohort. We will validate the radiomic signature on CT images, and further validation will be performed on CT images of the prospective cohorts collected and 70 screened individuals of the retrospective cohort. We will integrate results of biomarkers and radiomic data and will build a multiparametric risk model to improve early detection of lung cancer. The final predictive model will be then applied to the cohorts analysed and integrated with LDCT results to evaluate the improvement in diagnostic accuracy.
Measured: 01 July 2018 - 01 July 2021
Secondary outcomes (3)
Correlation of CTC spread to angiogenesis.
Number of CTC isolated with ISET technique in the prospective cohort of lung cancer patients and controls will be correlated to angiogenesis aspects of the primary tumor at CT scan, using dynamic perfusion data and quantitative and qualitative assessment of angiogenesis (surface fractal dimension and microvessel density) on hysthological examination.
Measured: 01 July 2018 - 01 July 2021
Assessment of epithelial mesenchymal transition (EMT) in CTC as a hallmark of poor prognosis.
The presence of CTC passed through EMT will be identified using immunoistochimical specific exams. The correlation between the presence of CTCs in EMT and prognostic factors of primary tumor (disease stage, volume doubling time, etc) will show the possible prognostic role of CTC immunoistochemical analysis.
Measured: 01 July 2018 - 01 July 2021
Standardise a method for genomic analysis from isolated CTCs for the early detection of resistance to treatments
A population of patients with advanced stage disease (stage III and IV) will be first analyzed to enrich for CTCs in the collected blood samples. This would help the initial refinement of the experimental protocol to detect CTC and analyse their mutational profile by single-cell NGS analysis. In addition, since most of these patients will undergo systemic treatment, we will setup a longitudinal study where the mutational profile of CTC will be investigated and correlated to chemotherapy response, to early identify theranostic mutations. The same refined protocol will be next validated on the prospective cohort of LDCT screened patients to further prove its validity to early detect cancer driver mutations.
Measured: 01 July 2018 - 01 July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jul 2018
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, University of Paris 5 - Rene Descartes, Maastricht University, Medical University of Gdansk, Erasmus Medical Center, University of Wuerzburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323579
- Sponsor's protocol ID
- 2122
- Acronym
- CLEARLY
- Status last verified
- Mar 2020
- First submitted
- 10 Jan 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.
- ClinicalTrials.gov ID
- NCT04323579
- Acronym / sponsor ID
- CLEARLY / 2122
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, University of Paris 5 - Rene Descartes, Maastricht University, Medical University of Gdansk, Erasmus Medical Center, University of Wuerzburg
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 26 Mar 2020 (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.
CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and radiomic signature, as complementary to assist early detection of lung cancer by low dose computed tomography-LDCT, using bioinformatics techniques; (b) assess the prognostic role of CTCs including the role of cells epithelial mesenchymal transition (EMT) and (c) standardize a method for genomic analysis of CTCs for early detection of treatment resistance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| prospective cohort of stage I-II lung cancer patients | – | –A prospective cohort of stage I-II lung cancer patients (N=80) candidates to surgery at Humanitas, and 40 controls with benign nodules. |
| retrospective screening cohort of 50 patients | – | –A retrospective screening cohort of 50 patients with screened lung cancer at MUG. |
| prospective screening cohort of 30 patients | – | –A prospective screening cohort of 30 patients with screened lung cancer and 100 matched negative controls enrolled at Humanitas cohort of 1000 participants (expected annual rate 1.5%). |
| retrospective screening cohort from the NELSON study | – | –A retrospective screening cohort from the NELSON study. |
| Prospective cohort of stage IV lung cancer patients | – | –A Prospective cohort of stage IV lung cancer patients (N=30) candidate to systemic therapy. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should have the following inclusion criteria: Inclusion Criteria: - Age ≥ 55 years old and exposure to smoking more than 30 packsyear; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%). - Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study. - Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Key inclusion criteria (3 listed)
- Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
- Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
- Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.
Key exclusion criteria (4 listed)
- Previous diagnosis of lung cancer.
- Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
- Performing a chest CT scan in the last 18 months.
- Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
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
Validation of the role of a bio-radiomic protocol as complementary tool to assist early detection of lung cancer by LDCT
Time frame: 01 July 2018 - 01 July 2021
CTC analysis will be performed using fresh plasma samples. Blood collection will be obtained for each lung cancer patient before and after surgery and once for controls. 45- and 16-miRNA signatures will be analyzed on plasma samples of the retrospective cohort (150 lung cancer patients and 120 matched controls). We will perform the exosome antigens analysis in the retrospective cohort. We will validate the 8-protein signature in the retrospective cohort. We will validate the radiomic signature on CT images, and further validation will be performed on CT images of the prospective cohorts collected and 70 screened individuals of the retrospective cohort. We will integrate results of biomarkers and radiomic data and will build a multiparametric risk model to improve early detection of lung cancer. The final predictive model will be then applied to the cohorts analysed and integrated with LDCT results to evaluate the improvement in diagnostic accuracy.
3 secondary outcomes
Correlation of CTC spread to angiogenesis.
Time frame: 01 July 2018 - 01 July 2021
Assessment of epithelial mesenchymal transition (EMT) in CTC as a hallmark of poor prognosis.
Time frame: 01 July 2018 - 01 July 2021
Standardise a method for genomic analysis from isolated CTCs for the early detection of resistance to treatments
Time frame: 01 July 2018 - 01 July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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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.
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 Lung Cancer, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Veronesi, MD (02 26435278, veronesi.giulia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the role of a bio-radiomic protocol as complementary tool to assist early detection of lung cancer by LDCT (time frame: 01 July 2018 - 01 July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.