UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038016 |
|---|---|
| Receipt number | R000043338 |
| Scientific Title | The role of novel biomarker HE4 in the follow-up of ovarian cancer |
| Date of disclosure of the study information | 2019/09/17 |
| Last modified on | 2025/03/23 10:16:19 |
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Basic information
Public title
The role of novel biomarker HE4 in the follow-up of ovarian cancer
Acronym
The role of novel biomarker HE4 in the follow-up of ovarian cancer
Scientific Title
The role of novel biomarker HE4 in the follow-up of ovarian cancer
Scientific Title:Acronym
The role of novel biomarker HE4 in the follow-up of ovarian cancer
Region
| Japan |
Condition
Condition
ovarian cancer, follopian tube cancer, primary peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical usefulness of HE4 for follow-up in patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To search for the optimal index for detection of recurrence by the increasing of HE4 values.
Key secondary outcomes
1. To compare the recurrence detection time in the optimal index of HE4 with the recurrence diagnosis time by image detection.
2. Search for factors that affect recurrence, therapeutic efficacy, and prognosis.
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
1. ovarian cancer, follopian tube cancer, or primary peritoneal cancer.
2. clinical stage III or IV.
3. CA125 (U/mL): 35 or more.
4. HE4 (pmol/L): 70 or more (premenopause), 140 or more (postmenopause).
5. no therapy
Key exclusion criteria
1. other malignancy
2. Patients judged inappropriate by the doctor
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7376
ytakei@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7376
Homepage URL
ytakei@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gynecologic Oncology, Saitama Medical University International Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Jichi Medical University Hospital
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-7550
rinri@jichi.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
自治医科大学（栃木県）
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 17 | 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
45
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data cleaning in progress.
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
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
1. Survey item: age, menopause, HBOC, primary site, stage, histology, cytology, tumor diameter, ascites, chemotherapy, operation, recurrence, survival
2. Examination item: pelvic examination, ultrasonography, blood sampling, MRI, CT (or PET)
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043338
