Lung AdenocarcinomaNCT06104709
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma and Local Cryoablation, run by China-Japan Friendship Hospital.
Trial summary
The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are: local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Adenocarcinoma, Local Cryoablation
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung adenocarcinoma who have indictions of local cryoablation without any other contraindications.
Who may be able to join
- Primary or metastatic lung cancer with definite pathological diagnosis.
- Patients are not suitable for thoracotomy due to serious lung or systemic disease.
- Peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection.
- There are indications for surgical resection, but the patient refuses surgery.
- Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum diameter ≤3cm.
- ECOG-PS score≤2.
Show all 9Show fewer
- Patients with an expected survival of more than three months.
- Patients have not participated in other clinical validation within 3 months.
- Subjects voluntarily sign informed consent.
Who cannot join
- Serious heart and brain disease or other mental illness.
- Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
- Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla.
- A history of immunodeficiency, including a positive HIV test (enzyme-linked immunoassay and Western spot assay).
- Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment.
- There is a serious bleeding tendency, platelets less than 50×109 /L and coagulation function is seriously disturbed.
Show all 14Show fewer
- Coagulation index (PT, TT, APTT) > 2.5 times the upper limit of normal.
- Ablation of ipsilateral malignant pleural effusion is not well controlled.
- Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorders.
- Patients with extensive extrapulmonary metastasis are not suitable for ablative therapy.
- People who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs.
- Pregnant or breastfeeding women.
- Patients who cannot evaluate the efficacy.
- Other conditions determined by the investigators to be unsuitable for inclusion, such as inability to tolerate cryoablation surgery, difficulty in follow-up, and other serious diseases.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are:
- local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation.
- local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation.
Peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.
- Conditions
- Lung Adenocarcinoma, Local Cryoablation
- Keywords
- Lung Adenocarcinoma, local cryoablation, immune landscape, metabolic changes
- Medical subject headings
- Adenocarcinoma of Lung
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 |
|---|---|---|
| LUAD patients undergoing cryoablation | No interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cryoablation completion
patients complete local cryoablation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104709
- Sponsor's protocol ID
- ZRJY2021-BJ08-02-06
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06104709
- Acronym / sponsor ID
- ZRJY2021-BJ08-02-06
- Conditions
- Lung Adenocarcinoma, Local Cryoablation
- Keywords
- Lung Adenocarcinoma, local cryoablation, immune landscape, metabolic changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Oct 2023 (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 goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are:
- local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation.
- local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation.
Peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUAD patients undergoing cryoablation | – | –No interventions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung adenocarcinoma who have indictions of local cryoablation without any other contraindications.
Key inclusion criteria (9 listed)
- Primary or metastatic lung cancer with definite pathological diagnosis.
- Patients are not suitable for thoracotomy due to serious lung or systemic disease.
- Peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection.
- There are indications for surgical resection, but the patient refuses surgery.
- Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum diameter ≤3cm.
Key exclusion criteria (14 listed)
- Serious heart and brain disease or other mental illness.
- Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
- Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla.
- A history of immunodeficiency, including a positive HIV test (enzyme-linked immunoassay and Western spot assay).
- Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment.
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
cryoablation completion
Time frame: 1 month
patients complete local cryoablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Related trials for Lung Adenocarcinoma
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingObservational study
ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort
HCC - Hepatocellular Carcinoma, CRC (Colorectal 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma and Local Cryoablation, run by China-Japan Friendship Hospital.
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 9 inclusion and 14 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cryoablation completion (time frame: 1 month). 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 27 Oct 2023.