UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047614 |
|---|---|
| Receipt number | R000054296 |
| Scientific Title | Lepidic growth component as a favorable prognostic factor in non-small cell lung cancer |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2022/04/28 13:02:09 |
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Basic information
Public title
Lepidic growth component as a favorable prognostic factor in non-small cell lung cancer
Acronym
Lepidic growth component is prognostic factor
Scientific Title
Lepidic growth component as a favorable prognostic factor in non-small cell lung cancer
Scientific Title:Acronym
Lepidic growth component is prognostic factor
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Many non-small cell lung cancer (NSCLC) tumors present a complex histology composed of various components. While the effects of several components on the prognosis of NSCLC have been investigated, no studies have investigated the prognosis of NSCLC with a lepidic growth component (LGC). Here, we attempted to clarify whether an LGC is an important prognostic factor for NSCLC.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We retrospectively reviewed the clinicopathologic features of 379 patients with NSCLC who underwent radical surgical resection between 2004 and 2016 at the University of Yamanashi Hospital. The histologic subtypes were classified into the LGC group (NSCLC with an LGC) and the non-LGC group (NSCLC without an LGC). We evaluated the effect of an LGC on the clinicopathologic features and 5-year overall survival of patients with NSCLC using a Cox proportional hazards model and a log-rank test by matching with the pathologic invasive size.
Key secondary outcomes
Base
Study type
Observational
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criterion was complete resected NSCLC.
Key exclusion criteria
The exclusion criteria were as follows: a) diagnosis of small cell lung cancer of any size, adenocarcinoma in situ, or synchronous lung cancer; b) previous preoperative chemotherapy or radiotherapy; c) stage IV disease; and d) insufficient data lacking clinical, pathological, or prognostic information.
Target sample size
975
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
University of Yamanashi
Division name
Department of Thoracic Surgery
Zip code
409-3898
Address
1110, Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan
TEL
055-273-1111
satoh.dsuke@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
University of Yamanashi
Division name
Department of Thoracic Surgery
Zip code
409-3898
Address
1110, Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan
TEL
055-273-1111
Homepage URL
satoh.dsuke@gmail.com
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
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
University of Yamanashi
Address
1110, Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan
Tel
055-273-1111
satoh.dsuke@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2469
Org. issuing International ID_1
University of Yamanashi
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山梨大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 30 | 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
975
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054296
