UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039209
Receipt number 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 2024/01/24 10:44:28

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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 or person

Institute

Department of Radiology, Tokyo Medical University

Institute

Department

Personal name



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

東京医科大学病院(東京都)


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

29

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

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

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


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

2024 Year 01 Month 24 Day



Link to view the page

Value
https://center6.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