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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039209
Receipt No. R000044712
Scientific Title Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Date of disclosure of the study information 2020/01/21
Last modified on 2020/01/21

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Basic information
Public title Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Acronym Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Scientific Title Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Scientific Title:Acronym Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Although radiotherapy is effective for treating various forms of lung cancer, radiotherapy-related toxicities of radiation pneumonitis (RP) can be life-threatening. However, predicting RP before radiotherapy is still difficult because patient-related factors are not fully understood. Thus, we investigated saliva metabolites to search for independent patient-related risk factors for predicting future RP.
Basic objectives2 Others
Basic objectives -Others Evaluation of changes in saliva metabolites associated with radiotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We collected patients' saliva metabolites before, 2 weeks after, and 3 months after the start of radiotherapy, and just after the end of treatment. To search for independent patient-related risk factors for predicting future radiation pneumonitis using saliva metabolomes.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Twenty years of age or older; patients histologically diagnosed with non-small cell lung cancer (NSCLC), or diagnosed by the cancer board conference, in case where the histological diagnosis appears risky.
2)Patients suitable for curative radiotherapy
3)No history of thoracic radiotherapy
Key exclusion criteria 1)Patients with active interstitial pneumonia
2)Patients with severe liver cirrhosis, diabetes mellitus or cardiovascular diseases
3) Patients with malignancies other than lung cancer
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Sachika
Middle name
Last name Shiraishi
Organization Tokyo Medical University
Division name Department of radiology
Zip code 1600023
Address 6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
TEL 0333426111
Email s-nogi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Sachika
Middle name
Last name Shiraishi
Organization Toyko Medical University
Division name Department of radiology
Zip code 1600023
Address 6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
TEL 0333426111
Homepage URL
Email s-nogi@tokyo-med.ac.jp

Sponsor
Institute Department of Radiology, Tokyo Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 IRB comittee, Tokyo Medical University
Address 6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
Tel 0333426111
Email IRB@tokyo-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
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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 17 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2020 Year 01 Month 21 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 Registration period is determined to be two years. The follow up period is set to be another 1 year from the end of the radiotherapy.

Management information
Registered date
2020 Year 01 Month 21 Day
Last modified on
2020 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044712

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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