Advanced Non-small-cell Lung CancerNCT05380908
Brain Metabolic Network of PET in Patients With Advanced Non-Small Cell Lung Cancer
An observational study of Advanced Non-small-cell Lung Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is a retrospective study, screening patients with systemic PET / CT scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain PET images.Then make the brain metabolic network analysis and statistical analysis to explore the PET brain metabolic… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Advanced Non-small-cell Lung Cancer
- What is being tested?
- None of any intervention
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 28 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with pathological confirmed non-small cell lung cancer
Who may be able to join
- Patients with advanced non-small cell lung cancer without any treatment and pathological confirmed non-small cell lung cancer.
Who cannot join
- Brain tumors (primary or metastasis), previous surgery, radiotherapy, chemotherapy, stroke, head trauma, psychiatric history (insomnia, depression, mania, schizophrenia and other psychiatric disorders), or history of drug dependence (e. g. sedatives, sleeping pills or sedatives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Fifth Affiliated Hospital of Sun Yat-sen University
This study is a retrospective study, screening patients with systemic PET / CT scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain PET images.Then make the brain metabolic network analysis and statistical analysis to explore the PET brain metabolic network of non-small cell lung cancer patients and the effect of chemotherapy drugs on brain metabolic network in patients with advanced lung cancer.
Read the detailed description
- Enroll Participants
- Collect PET/CT Images
- Images Analysis
- Statistical Analysis
- Conditions
- Advanced Non-small-cell Lung Cancer
- Being tested
- None of any intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None of any interventionOther
The patients did not have any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with untreated non-small cell lung cancer | Not described Receives: Other: None of any intervention | |
| Patients with non-small cell lung cancer after chemotherapy | Not described | |
| Normal controls | Not described Receives: Other: None of any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small-cell Lung CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380908
- Sponsor's protocol ID
- K059(2021-059)
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fifth Affiliated Hospital of Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT05380908
- Acronym / sponsor ID
- K059(2021-059)
- Conditions
- Advanced Non-small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 19 May 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.
This study is a retrospective study, screening patients with systemic PET / CT scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain PET images.Then make the brain metabolic network analysis and statistical analysis to explore the PET brain metabolic network of non-small cell lung cancer patients and the effect of chemotherapy drugs on brain metabolic network in patients with advanced lung cancer.
Detailed description
- Enroll Participants
- Collect PET/CT Images
- Images Analysis
- Statistical Analysis
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with untreated non-small cell lung cancer | – | Other: None of any intervention |
| Patients with non-small cell lung cancer after chemotherapy | – | – |
| Normal controls | – | Other: None of any intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathological confirmed non-small cell lung cancer
Key inclusion criteria (1 listed)
- Patients with advanced non-small cell lung cancer without any treatment and pathological confirmed non-small cell lung cancer.
Key exclusion criteria (1 listed)
- Brain tumors (primary or metastasis), previous surgery, radiotherapy, chemotherapy, stroke, head trauma, psychiatric history (insomnia, depression, mania, schizophrenia and other psychiatric disorders), or history of drug dependence (e. g. sedatives, sleeping pills or sedatives)
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 |
|---|---|---|
| None of any interventionThe patients did not have any intervention. | Other | Normal controls, Patients with untreated non-small cell lung cancer |
Primary outcome
Death
Time frame: 1-5 years
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 19 May 2022.
- Individual participant dataSharing planned: No
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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.
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 Advanced Non-small-cell Lung Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 19 May 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 China. 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?
Death (time frame: 1-5 years). 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 19 May 2022.