UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027121 |
|---|---|
| Receipt number | R000031082 |
| Scientific Title | A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the cervical cancer |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2025/05/01 14:03:58 |
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Basic information
Public title
A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the cervical cancer
Acronym
A prospective study of the usefulness of liquid biopsy as biomarker for the cervical cancer
Scientific Title
A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the cervical cancer
Scientific Title:Acronym
A prospective study of the usefulness of liquid biopsy as biomarker for the cervical cancer
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to determine the usefulness of liquid biopsy as biomarker for cervical cancer by concordance rate of liquid biopsy and gene mutation in tumor tissue specimen.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between gene mutation by liquid biopsy and progression free survival.
Key secondary outcomes
PFS by liquid biopsy
OS by liquid biopsy
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
The patients with cervical cancer who are planned to treat according our protocol.
Key exclusion criteria
The patients are followed our protocol.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Ino |
Organization
Wakayama medical university
Division name
Obstetrics and gynecology
Zip code
641-0012
Address
811-1 Kimiidera Wakayama, Japan
TEL
0734410631
kazuino@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Iwahashi |
Organization
Wakayama Medical University
Division name
Obstetrics and gynecology
Zip code
641-0012
Address
811-1 Kimiidera Wakayama, Japan
TEL
0734410631
Homepage URL
naoyuki@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
research expense
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Genome Biology, Kindai University Faculty of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Obstetrics and Gynecology, Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Japan
Tel
073-441-0631
naoyuki@wakayama-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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 08 | 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
| Delay expected |
Results Delay Reason
Not enough samples
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
| 2017 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observing
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031082
