UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058510 |
|---|---|
| Receipt number | R000066854 |
| Scientific Title | A Study on Cancer Screening for Individuals with Inconclusive NIPT Results |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/21 10:31:45 |
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Basic information
Public title
A Study on Cancer Screening for Individuals with Inconclusive NIPT Results
Acronym
A Study on Cancer Screening for Individuals with Inconclusive NIPT Results
Scientific Title
A Study on Cancer Screening for Individuals with Inconclusive NIPT Results
Scientific Title:Acronym
A Study on Cancer Screening for Individuals with Inconclusive NIPT Results
Region
| Japan |
Condition
Condition
Individuals with inconclusive NIPT results
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to elucidate the association between inconclusive results of non-invasive prenatal testing (NIPT) and maternal malignancies by performing whole-body MRI-based cancer screening in pregnant women with inconclusive NIPT findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of cancers detected by whole-body MRI
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
MRI scan
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Individuals aged 18 years or older at the time of obtaining consent.
2.Pregnant individuals at 14 weeks of gestation or later, with an ongoing pregnancy and eligible for whole-body MRI.
3.Individuals who have received a thorough explanation of the study, fully understood its contents, and voluntarily provided written informed consent to participate.
Key exclusion criteria
1.Individuals with contraindications to MRI examinations (e.g., metallic implants, pacemakers).
2.Individuals with a history of malignant tumors.
3.Individuals deemed inappropriate for participation in the study by the principal investigator for any other reason.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Umazume |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and the Perinatal Center
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5941
takeuma@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Umazume |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and the Perinatal Center
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5941
Homepage URL
takeuma@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research Administration Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-716-1161
crjimu@huhp.hokudai.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
| 2025 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066854
