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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013407
Receipt No. R000015645
Scientific Title The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung
Date of disclosure of the study information 2014/03/13
Last modified on 2015/09/15

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Basic information
Public title The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung
Acronym The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung
Scientific Title The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung
Scientific Title:Acronym The biological behavior and prognostic factors in peripheral squamous cell carcinoma of the lung
Region
Japan

Condition
Condition peripheral squamous cell carcinoma of the lung
Classification by specialty
Surgery in general Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Squamous cell carcinomas (SqCCs) of the lung account for 20-30% of non-small cell lung cancers (NSCLC). Although the majority of SqCCs of the lung have histologically been reported to arise in the central bronchial regions, the incidence of SqCCs arising in the peripheral lung has increased over recent years. Several reports have revealed a low prevalence of lymph node metastasis in peripheral SqCCs (p-SqCCs), especially in tumors 2 cm or less in diameter. These facts support the idea that SqCCs remain localized and grow slowly compared with lung adenocarcinoma. However the characteristics and biological behaviors of p-SqCCs including prognostic factors remain to be elucidated.
Pathologically proven lymphovascular and pleural invasion are generally correlated with poor outcome and they could predict cancer recurrence in NSCLC. Visceral pleural invasion is defined as invasion beyond the elastic layer and T1 tumors with pleural invasion is upgraded to T2a in the 7th TNM classification. Vascular invasion is also significantly correlated with cancer recurrence in early stage NSCLC. Although vascular and pleural invasion are useful prognostic factors for NSCLC, this has not yet been established especially among p-SqCCs patients. In this retrospective study, we evaluated several clinicopathological variables in patients with p-SqCCs in an attempt to identify reliable prognostic factors.
Basic objectives2 Others
Basic objectives -Others New proposal of TNM classification in peripheral squamous cell carcinoma of the lung.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival, recurrence free survival
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria They all underwent complete resection of p-SqCCs from January 1995 through December 2011 at our two institutes. All the patients had a solitary lesion.
Key exclusion criteria Patients who had received preoperative chemotherapy or thoracic radiotherapy were excluded.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsutomo Kohno
Organization Department of Surgery, Keio University School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL 03-5363-3806
Email kohno@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsutomo Kohno
Organization Department of Surgery, Keio University School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL 03-5363-3806
Homepage URL
Email kohno@a3.keio.jp

Sponsor
Institute Division of General Thoracic Surgery, Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of General Thoracic Surgery, Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information The result of this trial will be presented in academic meeting and article.

Management information
Registered date
2014 Year 03 Month 13 Day
Last modified on
2015 Year 09 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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