Lung CancerNCT05187767
Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs
An observational study of Lung Cancer and Spreading of Tumor, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Spreading of Tumor, Circulating Tumor Cell
- What is being tested?
- cf DNA and ct DNA
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to Oct 2024
- 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 with radiological finding of pulmonary ground glass opacity of unknown origin
Who may be able to join
- age> 18 years
- radiological finding of pulmonary ground glass opacity
- absence of solid or haematological tumor
Who cannot join
- radio / chemotherapy treatment for at least 6 months
- patient unable to understand and express his consent to the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Thoracic Surgery Unit, Sapienza University of Rome
Roma
Marco Anile, MD, +390649970220, marco.anile@uniroma1.it
Massimiliano Bassi, MD, +390649970220, massimiliano.bassi@uniroma1.it
About this study
Official title: Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities
The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.
Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.
- Conditions
- Lung Cancer, Spreading of Tumor, Circulating Tumor Cell
- Being tested
- cf DNA and ct DNA
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cf DNA and ct DNADiagnostic test
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA
| Study group | Role | What they receive |
|---|---|---|
| Malignant GGOs | Patients with histologically proven malignant pulmonary ground glass opacities (GGOs) Receives: Diagnostic Test: cf DNA and ct DNA | |
| Benign GGOs | Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs) Receives: Diagnostic Test: cf DNA and ct DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of cf DNA
Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0
Measured: through study completion, an average of 2 year
Presence of ct DNA
Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Apr 2022
- Primary completionJan 2024 (estimated)
- Study completionOct 2024 (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 University of Roma La SapienzaThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Anile, University of Roma La Sapienza
- Investigators
- Marco Anile, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187767
- Sponsor's protocol ID
- GGO ctDNA
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities
- ClinicalTrials.gov ID
- NCT05187767
- Acronym / sponsor ID
- GGO ctDNA
- Conditions
- Lung Cancer, Spreading of Tumor, Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Jan 2022 (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 aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.
Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant GGOs | – | Diagnostic Test: cf DNA and ct DNAPatients with histologically proven malignant pulmonary ground glass opacities (GGOs) |
| Benign GGOs | – | Diagnostic Test: cf DNA and ct DNAPatients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with radiological finding of pulmonary ground glass opacity of unknown origin
Key inclusion criteria (3 listed)
- age> 18 years
- radiological finding of pulmonary ground glass opacity
- absence of solid or haematological tumor
Key exclusion criteria (2 listed)
- radio / chemotherapy treatment for at least 6 months
- patient unable to understand and express his consent to the study
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 |
|---|---|---|
| cf DNA and ct DNAQuantification of the circulating free DNA and the presence of targeted circulating tumor DNA | Diagnostic test | Benign GGOs, Malignant GGOs |
Primary outcome
Quantification of cf DNA
Time frame: through study completion, an average of 2 year
Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0
Presence of ct DNA
Time frame: through study completion, an average of 2 year
Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marco Anile, MD principal investigator
University of Roma La Sapienza
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 and Spreading of Tumor, run by University of Roma La Sapienza 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 2 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 8 Nov 2022. 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 Marco Anile, MD (+390649970220, marco.anile@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of cf DNA (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. 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 8 Nov 2022.