UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056642 |
|---|---|
| Receipt number | R000064667 |
| Scientific Title | A Prospective multicenter study for evaluation of the Accuracy and clinical usefulness of the high-sensitivity NExt-generation sequencing panel using bronchial washing fluid from Lung cancer |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/06 20:51:01 |
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Basic information
Public title
A Prospective multicenter study for evaluation of the Accuracy and clinical usefulness of the high-sensitivity NExt-generation sequencing panel using bronchial washing fluid from Lung cancer
Acronym
cPANEL-2 trial
Scientific Title
A Prospective multicenter study for evaluation of the Accuracy and clinical usefulness of the high-sensitivity NExt-generation sequencing panel using bronchial washing fluid from Lung cancer
Scientific Title:Acronym
cPANEL-2 trial
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To verify the usefulness of lung cancer gene panel testing using bronchial washing fluids as a multicenter prospective study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of gene mutations in cytology-positive washing fluids (positive and negative agreement rates with the conventional method)
Key secondary outcomes
1. Correlation between gene mutation allele ratios using the conventional method and the washing method
2. Comparison of test success rates and nucleic acid yields (DNA/RNA) using the conventional method and the washing method
3. Gene mutation detection rate in cytology negative washing fluid
4. Gene mutation detection rate by disease stage/tumor size
5. Tumor cell count and tumor cell content in paired samples
6. Correlation between allele frequency and therapeutic effect of molecular targeted drugs
7. Correlation between positive/negative agreement rate and allele frequency of plasma compact panel test with conventional method
8. Positive/negative agreement rate of plasma compact panel test with Cobas test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Bronchoscopy is performed for diagnostic purposes in patients suspected of malignant lung tumor. First, a radial EBUS is inserted into the access bronchus estimated by prior bronchus sketching or navigation software, and once the lesions is confirmed, the radial EBUS is removed. The scope is then wedged and washed with normal saline, and the washing fluids are collected in a container.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients suspected of having lung cancer (non-small cell lung cancer) and who require a cytological or tissue diagnosis.
2. Patients aged 20 years or older.
3. Patients who have given written informed consent to participate.
4. Patients expected to progress to clinical stage 3 (locally advanced stage) or advanced (stage 4).
Key exclusion criteria
Exclusion criteria (primary registration)
1) Patients who the principal investigator (physician) or co-investigator (physician) judges to be inappropriate for participation in this study.
Exclusion criteria (secondary registration)
1) Patients for whom saline injection is expected to affect subsequent direct procedures
2) Tumors clearly exposed under direct vision (epithelial changes due to lymphangiectasia carcinomatosis are acceptable)
3) Patients for whom identification of communicating bronchi or wedge of the scope is extremely difficult (the degree of wedge during bronchial lavage in daily practice is acceptable)
4) Tumor signals are not observed or are not within the tumor when rEBUS is inserted before saline injection
5) No malignant cells are confirmed by direct method (not a malignant lesion)
6) No malignant cells are confirmed by lavage fluid
Target sample size
93
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Morikawa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
0449778111
Address
Miyamae-ku Sugao 2-16-1
TEL
+81449778111
mokke@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Morikawa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
Miyamae-ku Sugao 2-16-1
TEL
+81449778111
Homepage URL
mokke@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
DNA Chip Research Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for Respiratory Endoscopy
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
Miyamae-ku Sugao 2-16-1
Tel
+81449778111
mokke@marianna-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Clinical trial number #6621
Org. issuing International ID_1
St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064667
