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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039202
Receipt No. R000044706
Scientific Title Exploration of novel predictor for lung cancer recurrence after radical surgery using mass spectrometry
Date of disclosure of the study information 2020/01/21
Last modified on 2020/01/20

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Basic information
Public title Exploration of novel predictor for lung cancer recurrence after radical surgery using mass spectrometry
Acronym Exploration of novel predictor for lung cancer recurrence after radical surgery using mass spectrometry
Scientific Title Exploration of novel predictor for lung cancer recurrence after radical surgery using mass spectrometry
Scientific Title:Acronym Exploration of novel predictor for lung cancer recurrence after radical surgery using mass spectrometry
Region
Japan

Condition
Condition non small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Predicting recurrence after radical surgery is difficult even with pathological prognostic factors reported ever. For efficient application of adjuvant chemotherapy, identifying recurrence high risk group who are likely to benefit from adjuvant chemotherapy is needed. In this study, we investigated potential predictive factors for non small lung cancer recurrence after radical surgery by comparing lipidomes of recurrent and non-recurrent non small lung cancer using mass spectrometry.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validating the area under the curve (AUC) of lipids which are increased or decreased in recurrent lung cancer.
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 Patients with pathological stage1or2 who had the indication for radical surgery, histological type of non small cell lung cancer were included.
Key exclusion criteria Patients who received induction chemotherapy or radiotherapy and patients with variants of adenocarcinoma were excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuhito
Middle name
Last name Funai
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan
TEL 0534352276
Email kfunai@hama-med.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Takanashi
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan
TEL 0534352276
Homepage URL https://www.hama-med.ac.jp/research/18-264.pdf
Email nashimed1@gmail.com

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan
Tel 0534352680
Email rinri@hama-med.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
2020 Year 01 Month 21 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 20
Results Average total lipids amount was increased in recurrent group compared to non-recurrent group (Folding change=1.65, p=0.026). 203 lipids were increased and 4 lipis were decreased in recurrent group. The increased lipids included sphingomyelin and ceramide which are reported to correlate with cancer progression. Area under the curve of sphingomyelin and ceramide for reccurent prediction were 9.1 and 9.0 respectively.
Results date posted
2020 Year 01 Month 20 Day
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
2019 Year 01 Month 15 Day
Date of IRB
2019 Year 01 Month 30 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective frozen tissue samples obtained from stage1-2 non small cell lung cancer patients who had undergone radical surgery at Hamamatsu University Hospital were recruited. Lipids extraction was performed by Bligh Dyer method and comparison of lipidomes between recurrent group and non-recurretnt group was done.

Management information
Registered date
2020 Year 01 Month 20 Day
Last modified on
2020 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044706

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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