UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051503 |
|---|---|
| Receipt number | R000058756 |
| Scientific Title | Comparison of the utility of multiplex tests for non-small cell lung cancer with necrosis-rich tumors. |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2023/07/02 23:32:21 |
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Basic information
Public title
Comparison of the utility of multiplex tests for non-small cell lung cancer with necrosis-rich tumors.
Acronym
Comparison of the utility of multiplex tests for non-small cell lung cancer with necrosis-rich tumors.
Scientific Title
Comparison of the utility of multiplex tests for non-small cell lung cancer with necrosis-rich tumors.
Scientific Title:Acronym
Comparison of the utility of multiplex tests for non-small cell lung cancer with necrosis-rich tumors.
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate appropriate testing in cases of necrosis-rich non-small cell lung cancer by performing and comparing various multi-gene tests on blood, FFPE and cytology specimens.
Basic objectives2
Others
Basic objectives -Others
Utility of various multigene tests for necrosis-rich non-small cell lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of analysis using ODxTT and AmoyDx with FFPE specimens and Compact Panel Dx with FFPE or cytology specimens.
Key secondary outcomes
Comparison of success rates between ODxTT and Compact Panel Dx; comparison of success rates between ODxTT and AmoyDx; driver gene detection rates by analysis using ODxTT and AmoyDx in FFPE specimens and Compact Panel Dx using FFPE or cytology specimens.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients whose FFPE led to a diagnosis of non-small cell lung cancer
(ii) Necrotic component >20% after macrodissection
(iii) Blood tests can be collected before treatment
(iv) Age at the time of obtaining consent must be 20 years or older
(v) Written consent to participate in this study has been obtained from the patient.
Key exclusion criteria
(i) Cases where it is deemed difficult to submit ODxTT and AmoyDx with FFPE specimens, and Compact Panel Dx with FFPE or cytology specimens due to sample volume, or where the aforementioned multi-gene tests make it difficult to submit other tests considered necessary in routine clinical practice.
(ii) Cases in which the tumor cell percentage is less than 30% even if macrodissection is performed.
(iii) Other cases deemed unsuitable by the physician in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine
Zip code
515-0073
Address
1550, Tonomachi, Matsusaka, Mie
TEL
+81598231515
iwbd0524@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine
Zip code
515-0073
Address
1550, Tonomachi, Matsusaka, Mie
TEL
+81598231515
Homepage URL
mchsakaguchi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka, Mie.
Tel
0598-23-1515
mch1031@city-hosp.matsusaka.mie.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 03 | 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
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is ongoing.
Management information
Registered date
| 2023 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
