Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: single-cell sequencing.
- Who it may be relevant to
- Registry conditions: Pneumonitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Single-cell Sequencing of Bronchoalveolar Lavage Fluid to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis
Overview
A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.
Detailed description
This study is a multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.
Interventions
- Genetic single-cell sequencing
Treatment is given according to the results of single-cell sequencing.
Primary outcome measures
- Response rate [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
- NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
- ≥18 years old, less than 75 years old;
- ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
- Patients without contraindications to alveolar lavage;
Exclusion criteria
- Poor patient compliance and violation of test regulations;
- Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
- Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
- Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
- Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
- Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \& LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
- Known history of HIV infection;
- Received any other investigational drug or participated in any other clinical trial within 28 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xinqiao Hospital — Chongqing
Publications
- Papalexi E, Satija R. Single-cell RNA sequencing to explore immune cell heterogeneity. Nat Rev Immunol. 2018 Jan;18(1):35-45. doi: 10.1038/nri.2017.76. Epub 2017 Aug 7. PMID 28787399
- Liao M, Liu Y, Yuan J, Wen Y, Xu G, Zhao J, Cheng L, Li J, Wang X, Wang F, Liu L, Amit I, Zhang S, Zhang Z. Single-cell landscape of bronchoalveolar immune cells in patients with COVID-19. Nat Med. 2020 Jun;26(6):842-844. doi: 10.1038/s41591-020-0901-9. Epub 2020 May 12. PMID 32398875
- Grun D, van Oudenaarden A. Design and Analysis of Single-Cell Sequencing Experiments. Cell. 2015 Nov 5;163(4):799-810. doi: 10.1016/j.cell.2015.10.039. PMID 26544934
Identifiers
NCT: NCT05455034 · XQonc-019