Lung NeoplasmNCT05854030
Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma
An observational study of Lung Neoplasm and Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasm, Squamous Cell Carcinoma, Exosomes
- What is being tested?
- collect plasma samples and clinical features
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Aug 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed as advanced lung squamous carcinoma by histopathology and be treated with anti-PD-L1 combined with chemotherapy
Who may be able to join
- Histology or cytology confirmed patients with stage IV squamous cell carcinoma of IASLC TNM (8th edition);
- Patients have not previously received first-line anti-tumor systemic therapy for advanced lung cancer;
- At least one measurable lesion according to the irRECIST 1.1 standard;
- Physical condition and organ function allow for systemic antitumor therapy, including standard chemotherapy and immunotherapy;
- Age ≥ 18 years at the time of signing the informed consent form;
- Estimated survival≥ 3 months;
- Patients can follow the planned schedule and actively cooperate in returning to the hospital for regular clinical follow-up and necessary treatment;
- It can provide the clinical data required for research and is willing to use the test data for further scientific research and commercial product development.
Who cannot join
- Other malignancies within the last 5 years (except adequately treated carcinoma in situ and basal or squamous cell skin cancer);
- The investigators judged that the patient also had other serious medical conditions that could affect follow-up and short-term survival;
- Any other medical condition and social/psychological problems which the investigator determines that the patient is not suitable to participate in this study;
- Contrast-enhanced MRI or contrast-enhanced CT for clinical follow-up is not acceptable;
- Have an active or previous auto-immune disease that is likely to recur;
- Other antineoplastic therapies were planned for the duration of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TianjinCIH
Tianjin, Tianjin Municipality, 300060
Richeng Jiang, Postdoctor, 02223340123, jiangricheng@tjmuch.com
Qin Chen, Doctor, 8615822048332, ruozhuxuan@163.com
About this study
Official title: A Study on Serum Exosomal miRNA Predicting the Effective and Prognosis of Immunotherapy Combined With Chemotherapy in Pulmonary Squamous Carcinoma
This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.
Read the detailed description
PD-L1 Testing in guiding patient selection for PD-1/PD-L1 inhibitor therapy in Lung Cancer exhibits insufficient sensitivity and efficacy. The investigators aimed to identify specific serum exosomal miRNA biomarkers that are highly sensitive and stable for predicting the therapeutic effect of immunotherapy combined with chemotherapy. So that the clinicians could use the biomarker to better stratify patients and select potential immunotherapy-beneficial subgroups before clinical decisions.
We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy.
Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs.
Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results.
Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy.
Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.
- Conditions
- Lung Neoplasm, Squamous Cell Carcinoma, Exosomes
- Being tested
- collect plasma samples and clinical features
- Keywords
- biomarker
- Medical subject headings
- Lung Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect plasma samples and clinical featuresDiagnostic test
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
| Study group | Role | What they receive |
|---|---|---|
| advanced lung squamous carcinoma | advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy Receives: Diagnostic Test: collect plasma samples and clinical features | |
| normol volunteers | 10 normol volunteers will be enrolled in the group Receives: Diagnostic Test: collect plasma samples and clinical features |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma exosomal miRNA level
The expression levels of serum exosome micro RNA
Measured: Baseline up to 21 days
PD-L1
the expression levels of PD-L1
Measured: Baseline up to 21 days
Imaging data of lesions
Imaging data of the pulmonary and metastatic lesions of the patients are collected
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate
Measured: From the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Richeng Richeng, Postdoctor, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854030
- Sponsor's protocol ID
- SCC-EV-2022
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh RJ, Soo RA. Resistance to immune checkpoint inhibitors in non-small cell lung cancer: biomarkers and therapeutic strategies. Ther Adv Med Oncol. 2020 Jul 3;12:1758835920937902. doi: 10.1177/1758835920937902. eCollection 2020.
PubMed 32670423Hansen AR, Siu LL. PD-L1 Testing in Cancer: Challenges in Companion Diagnostic Development. JAMA Oncol. 2016 Jan;2(1):15-6. doi: 10.1001/jamaoncol.2015.4685. No abstract available.
PubMed 26562503Sacher AG, Gandhi L. Biomarkers for the Clinical Use of PD-1/PD-L1 Inhibitors in Non-Small-Cell Lung Cancer: A Review. JAMA Oncol. 2016 Sep 1;2(9):1217-22. doi: 10.1001/jamaoncol.2016.0639.
PubMed 27310809Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.
PubMed 25765070Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
PubMed 28596308Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.
PubMed 33548389Mashouri L, Yousefi H, Aref AR, Ahadi AM, Molaei F, Alahari SK. Exosomes: composition, biogenesis, and mechanisms in cancer metastasis and drug resistance. Mol Cancer. 2019 Apr 2;18(1):75. doi: 10.1186/s12943-019-0991-5.
PubMed 30940145Correction: Correlation of plasma exosomal microRNAs with the efficacy of immunotherapy in EGFR / ALK wild-type advanced non-small cell lung cancer. J Immunother Cancer. 2020 May;8(1):e000376corr1. doi: 10.1136/jitc-2019-000376corr1. No abstract available.
PubMed 32434787Cazzoli R, Buttitta F, Di Nicola M, Malatesta S, Marchetti A, Rom WN, Pass HI. microRNAs derived from circulating exosomes as noninvasive biomarkers for screening and diagnosing lung cancer. J Thorac Oncol. 2013 Sep;8(9):1156-62. doi: 10.1097/JTO.0b013e318299ac32.
PubMed 23945385Zhang C, Chong X, Jiang F, Gao J, Chen Y, Jia K, Fan M, Liu X, An J, Li J, Zhang X, Shen L. Plasma extracellular vesicle derived protein profile predicting and monitoring immunotherapeutic outcomes of gastric cancer. J Extracell Vesicles. 2022 Apr;11(4):e12209. doi: 10.1002/jev2.12209.
PubMed 35362262Cordonnier M, Nardin C, Chanteloup G, Derangere V, Algros MP, Arnould L, Garrido C, Aubin F, Gobbo J. Tracking the evolution of circulating exosomal-PD-L1 to monitor melanoma patients. J Extracell Vesicles. 2020 Jan 7;9(1):1710899. doi: 10.1080/20013078.2019.1710899. eCollection 2020.
PubMed 32002173
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Serum Exosomal miRNA Predicting the Effective and Prognosis of Immunotherapy Combined With Chemotherapy in Pulmonary Squamous Carcinoma
- ClinicalTrials.gov ID
- NCT05854030
- Acronym / sponsor ID
- SCC-EV-2022
- Conditions
- Lung Neoplasm, Squamous Cell Carcinoma, Exosomes
- Keywords
- biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Chest Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 May 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.
This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.
Detailed description
PD-L1 Testing in guiding patient selection for PD-1/PD-L1 inhibitor therapy in Lung Cancer exhibits insufficient sensitivity and efficacy. The investigators aimed to identify specific serum exosomal miRNA biomarkers that are highly sensitive and stable for predicting the therapeutic effect of immunotherapy combined with chemotherapy. So that the clinicians could use the biomarker to better stratify patients and select potential immunotherapy-beneficial subgroups before clinical decisions.
We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy.
Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs.
Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results.
Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy.
Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advanced lung squamous carcinoma | – | Diagnostic Test: collect plasma samples and clinical featuresadvanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy |
| normol volunteers | – | Diagnostic Test: collect plasma samples and clinical features10 normol volunteers will be enrolled in the group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as advanced lung squamous carcinoma by histopathology and be treated with anti-PD-L1 combined with chemotherapy
Key inclusion criteria (8 listed)
- Histology or cytology confirmed patients with stage IV squamous cell carcinoma of IASLC TNM (8th edition);
- Patients have not previously received first-line anti-tumor systemic therapy for advanced lung cancer;
- At least one measurable lesion according to the irRECIST 1.1 standard;
- Physical condition and organ function allow for systemic antitumor therapy, including standard chemotherapy and immunotherapy;
- Age ≥ 18 years at the time of signing the informed consent form;
Key exclusion criteria (6 listed)
- Other malignancies within the last 5 years (except adequately treated carcinoma in situ and basal or squamous cell skin cancer);
- The investigators judged that the patient also had other serious medical conditions that could affect follow-up and short-term survival;
- Any other medical condition and social/psychological problems which the investigator determines that the patient is not suitable to participate in this study;
- Contrast-enhanced MRI or contrast-enhanced CT for clinical follow-up is not acceptable;
- Have an active or previous auto-immune disease that is likely to recur;
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 |
|---|---|---|
| collect plasma samples and clinical features8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately | Diagnostic test | advanced lung squamous carcinoma, normol volunteers |
Primary outcome
plasma exosomal miRNA level
Time frame: Baseline up to 21 days
The expression levels of serum exosome micro RNA
PD-L1
Time frame: Baseline up to 21 days
the expression levels of PD-L1
Imaging data of lesions
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Imaging data of the pulmonary and metastatic lesions of the patients are collected
Objective response rate
Time frame: From the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Results publication: PubMed 32670423Walsh RJ, Soo RA. Resistance to immune checkpoint inhibitors in non-small cell lung cancer: biomarkers and therapeutic strategies. Ther Adv Med Oncol. 2020 Jul 3;12:1758835920937902. doi: 10.1177/1758835920937902. eCollection 2020.
- Results publication: PubMed 26562503Hansen AR, Siu LL. PD-L1 Testing in Cancer: Challenges in Companion Diagnostic Development. JAMA Oncol. 2016 Jan;2(1):15-6. doi: 10.1001/jamaoncol.2015.4685. No abstract available.
- Results publication: PubMed 27310809Sacher AG, Gandhi L. Biomarkers for the Clinical Use of PD-1/PD-L1 Inhibitors in Non-Small-Cell Lung Cancer: A Review. JAMA Oncol. 2016 Sep 1;2(9):1217-22. doi: 10.1001/jamaoncol.2016.0639.
- Results publication: PubMed 25765070Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.
- Results publication: PubMed 28596308Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
- Results publication: PubMed 33548389Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.
- Results publication: PubMed 30940145Mashouri L, Yousefi H, Aref AR, Ahadi AM, Molaei F, Alahari SK. Exosomes: composition, biogenesis, and mechanisms in cancer metastasis and drug resistance. Mol Cancer. 2019 Apr 2;18(1):75. doi: 10.1186/s12943-019-0991-5.
- Results publication: PubMed 32434787Correction: Correlation of plasma exosomal microRNAs with the efficacy of immunotherapy in EGFR / ALK wild-type advanced non-small cell lung cancer. J Immunother Cancer. 2020 May;8(1):e000376corr1. doi: 10.1136/jitc-2019-000376corr1. No abstract available.
- Results publication: PubMed 23945385Cazzoli R, Buttitta F, Di Nicola M, Malatesta S, Marchetti A, Rom WN, Pass HI. microRNAs derived from circulating exosomes as noninvasive biomarkers for screening and diagnosing lung cancer. J Thorac Oncol. 2013 Sep;8(9):1156-62. doi: 10.1097/JTO.0b013e318299ac32.
- Results publication: PubMed 35362262Zhang C, Chong X, Jiang F, Gao J, Chen Y, Jia K, Fan M, Liu X, An J, Li J, Zhang X, Shen L. Plasma extracellular vesicle derived protein profile predicting and monitoring immunotherapeutic outcomes of gastric cancer. J Extracell Vesicles. 2022 Apr;11(4):e12209. doi: 10.1002/jev2.12209.
- Results publication: PubMed 32002173Cordonnier M, Nardin C, Chanteloup G, Derangere V, Algros MP, Arnould L, Garrido C, Aubin F, Gobbo J. Tracking the evolution of circulating exosomal-PD-L1 to monitor melanoma patients. J Extracell Vesicles. 2020 Jan 7;9(1):1710899. doi: 10.1080/20013078.2019.1710899. eCollection 2020.
- 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.
Richeng Richeng, Postdoctor study chair
Tianjin Medical University Cancer Institute and Hospital
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 Neoplasm and Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 8 inclusion and 6 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 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richeng Jiang, Postdoctor (862223340123, jiangricheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma exosomal miRNA level (time frame: Baseline up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854030, which also lists 11 linked publications.
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 11 May 2023.