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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010117
Receipt No. R000011460
Scientific Title Study of clinicopathology and molecular biology on small-cell lung carcinoma
Date of disclosure of the study information 2013/02/25
Last modified on 2019/10/01

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Basic information
Public title Study of clinicopathology and molecular biology on small-cell lung carcinoma
Acronym Pathological and molecular analysis of small-cell lung carcinoma
Scientific Title Study of clinicopathology and molecular biology on small-cell lung carcinoma
Scientific Title:Acronym Pathological and molecular analysis of small-cell lung carcinoma
Region
Japan

Condition
Condition small-cell lung carcinoma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the protein expression and gene mutation profile of small-cell lung carcinoma, thereby clarify the clinicopathological and molecular factors related to prognosis and druggable target
Basic objectives2 Others
Basic objectives -Others Immunohistochemistry and mutational analysis using next generation sequencing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify the clinicopathological and molecular factors related to prognosis and druggable target
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 1) The patients with histologically confirmed small-cell lung carcinoma resected surgically in the institutes affiliated with Fukushima Lung Cancer Study Group and/or Hokkaido Lung Cancer Clinical Study Group, and other cooperation hospitals from Jan. 2003 through Jan. 2013.
2) Patient consent for use of surgically resected specimen
Key exclusion criteria 1) Histologically undiagnosed disease
2) Specimen resected surgically in the institutes that are not affiliated either with Fukushima Lung Cancer Study Group/Hokkaido Lung Cancer Clinical Study Group or our cooperation hospital network
3) Surgical specimen that was not obtained from Jan. 2003 through Jan. 2013.
4) In the case that the patient consent for use of surgically resected specimen is not obtained
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Yokouchi
Organization Fukushima Medical University, School of Medicine
Division name Department of Pulmonary Medicine
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1360
Email pulmo@fmu.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Yokouchi
Organization Fukushima Medical University, School of Medicine
Division name Department of Pulmonary Medicine
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1360
Homepage URL
Email hyokouch@gmail.com

Sponsor
Institute Fukushima Medical University Clinical Oncology Center
Institute
Department

Funding Source
Organization Fukushima Medical University Clinical Oncology Center, Center For Respiratory Disease, Hokkaido Social Insurance Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1 Hikariga-oka, Fukushima
Tel 024-547-1825
Email rs@fmu.ac.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
2013 Year 02 Month 25 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/28055980
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28055980
Number of participants that the trial has enrolled 107
Results
Of the 125 evaluable samples, all tumors expressed MED12, and 123 samples (98.4%) expressed TGF-bRII. High c-kit expression was an independent favorable prognosic marker confirmed by multivariate analysis (hazard ratio: 0.543, 95% confidence interval: 0.310-0.953, p=0.033).
Results date posted
2019 Year 10 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 70 years, 25 (23.4%) patients were female, and 9 (8.4%) were never-smokers. Thirty-three patients (30.8%) had a history or presence of other types of cancer. The numbers of patients with SCLC and combined SCLC were 76 (71.0%) and 31 (29.0%), respectively. The detailed histology which combined with SCLC was as follows: adenocarcinoma (n=10), squamous cell carcinoma (n=7), large cell carcinoma (n=5), large cell neuroendocrine carcinoma (LCNEC) (n=5), adenocarcinoma with LCNEC (n=2), adenocarcinoma with squamous cell carcinoma (n=1), and squamous cell carcinoma with large cell carcinoma (n=1). The clinical stages (TNM version 7) were IA (n=71), IB (n=9), IIA (n=10), IIB (n=6), IIIA (n=10), and IIIB (n=1). The majority of the patients underwent lobectomy (72.9%) along with regional hilar-mediastinal lymph node dissection (65.4%). Adjuvant chemotherapy was conducted in 67 (62.6%) patients, including eight who received chemoradiotherapy and two who received neo-adjuvant and adjuvant chemotherapy.
Participant flow
Analyses of the association between disease-specific survival and the expression of EGFR, c-kit, human EGFR-related 2 (HER2), c-Met, vascular endothelial growth factor receptor (VEGFR) II, ALK, MED12, and TGF-bRII by IHC were performed. 
Adverse events
None because this study was a retrospective observational study
Outcome measures
High c-kit expression was an independent favorable prognostic marker confirmed by multivariate analysis 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 02 Month 24 Day
Date of IRB
2013 Year 02 Month 25 Day
Anticipated trial start date
2013 Year 02 Month 25 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information immunohistochemistry and mutational analysis using next generation sequencing

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011460

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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