UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010117 |
|---|---|
| Receipt number | 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 21:17:57 |
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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
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
hyokouch@gmail.com
Sponsor or person
Institute
Fukushima Medical University Clinical Oncology Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011460
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