UMIN-CTR Clinical Trial

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
Email	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
Email	satoh.dsuke@gmail.com

Sponsor
Institute	University of Yamanashi
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054296