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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028021
Receipt No. R000031838
Scientific Title Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Date of disclosure of the study information 2017/07/01
Last modified on 2019/07/02

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Basic information
Public title Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Acronym Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Scientific Title Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Scientific Title:Acronym Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation between radiation doses and salivary gland functions in patients with head and neck cancer treated with whole neck radiotherapy. Salivary gland scintigraphy is performed three times before radiotherapy, and three months after the initiation of radiotherapy and then one year after.
Basic objectives2 Others
Basic objectives -Others Translational study: Evaluation of predictive and prognostic factors
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To assess the scores of salivary gland secretion amounts and recovery rates by the salivary gland scintigraphy before and after radiotherapy
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) Pathologically proven as head and neck cancer patients over 20 years of age.
2) Patients with preserved salivary gland functions
3) Patient with Performance Status of 0-1.
4) Patients without autoimmune diseases, such as Sjogren's syndrome
5) Patients who are able to provide written informed consents
Key exclusion criteria 1) Prognosis is expected to be less than 6 months
2) Suffering from severe underlying diseases, such as liver cirrhosis, diabetes mellitus and heart diseases
3) Suffering from severe allergic reactions to drugs
4) Pregnant or breast-feeding women, or women who may become or want to become pregnant in the near future
5) No previous history of receiving whole neck radiotherapy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Itonaga
Organization Tokyo Medical University
Division name Department of radiology
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
TEL 0333426111
Email itonaga@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Itonaga
Organization Tokyo Medical University
Division name Department of radiology
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
TEL 0333426111
Homepage URL
Email itonaga@tokyo-med.ac.jp

Sponsor
Institute Department of radiology,Tokyo Medical University
Institute
Department

Funding Source
Organization Department of radiology,Tokyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB committee, Tokyo Medical University
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
Tel 03-3342-6111
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
2017 Year 07 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 25 Day
Date of IRB
2017 Year 04 Month 25 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2019 Year 12 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, so in total 3 years will be necessary.

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031838

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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