UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021572 |
|---|---|
| Receipt number | R000024875 |
| Scientific Title | Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma |
| Date of disclosure of the study information | 2016/03/23 |
| Last modified on | 2024/04/19 22:01:04 |
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Basic information
Public title
Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma
Acronym
Biomarker research on the HPV infection for oropharyngeal carcinoma
Scientific Title
Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma
Scientific Title:Acronym
Biomarker research on the HPV infection for oropharyngeal carcinoma
Region
| Japan |
Condition
Condition
Oropharyngeal squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We research an association between the effect of the oropharyngeal squamous cell carcinoma and the HPV infection on the chemoradiotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of multimodal therapy and HPV infection for oropharyngeal carcinoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
chemotherapy, chemoradiotherapy
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
oropharyngeal squamous cell carcinoma
Stage III/IV
PS 0,1
No prior treatment
Key exclusion criteria
Patient with surgical treatment
Distant metastasis
Double cancer
Target sample size
213
Research contact person
Name of lead principal investigator
| 1st name | Katsunari |
| Middle name | |
| Last name | Yane |
Organization
Kindai University Nara Hospital
Division name
Otorhinolaryngology
Zip code
630-0293
Address
1248-1,Otoda,Ikoma,nara
TEL
0743-77-0880
kyane@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Katsunari |
| Middle name | |
| Last name | Yane |
Organization
Kindai University Nara Hospital
Division name
Otorhinolaryngology
Zip code
630-0293
Address
1248-1,Otoda,Ikoma,nara
TEL
0743-77-0880
Homepage URL
kyane@med.kindai.ac.jp
Sponsor or person
Institute
The study group of basic research of the head and neck
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Kindai University Nara Hospital
Address
1248-1,Otoda,Ikoma,nara
Tel
0743-77-0880
ikyokujimu@med.kindai.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
| 2016 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
https://www.med.kindai.ac.jp/nara/departments_and_centers/other/irb/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.med.kindai.ac.jp/nara/departments_and_centers/other/irb/
Number of participants that the trial has enrolled
80
Results
Among 80 samples, HPV positive oropharyngeal squamous cell carcinoma was 56 cases and HPV negative was 24 cases. Among HPV positive cases HPV16 was 49 cases, HPV35 was 3 cases respectively. In HPV positive samples, PIK3CA was the most common genomic alteration, the second one was FGFR3 and the third one was PTEN. In HPV negative samples, TP53 was most frequently altered. HPV positive patients had significantly better overall survival and disease free survival than HPV negative.
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with newly diagnosed oropharyngeal squamous cell carcinoma stage 3,4 and over 20 years old, performance status was from 0 to 2, treated with multimodal therapy mainly by chemo-radio therapy were registered.
Participant flow
The eighty samples were obtained in patients with previously untreated stage 3, 4 oropharyngeal squamous cell carcinoma who underwent multidisciplinary therapy at 14 Japanese hospitals that were the member of the Japan Cooperative Study Group for Basic Research in Head and Neck Cancer from May 2014 to March 2016.
Adverse events
No adverse event
Outcome measures
Primary endpoint : overall survival
Secondary endpoint : disease-free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Accompanying study of UMIN000013476
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024875
