UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059034 |
|---|---|
| Receipt number | R000067524 |
| Scientific Title | Assessment of minimal residual disease using droplet digital PCR in cryopreserved ovarian tissue sections from pediatric and adolescent female cancer patients undergoing fertility preservation |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/09 14:12:16 |
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Basic information
Public title
Assessment of minimal residual disease using droplet digital PCR in cryopreserved ovarian tissue sections from pediatric and adolescent female cancer patients undergoing fertility preservation
Acronym
Assessment of minimal residual disease using droplet digital PCR in cryopreserved ovarian tissue sections from pediatric and adolescent female cancer patients undergoing fertility preservation
Scientific Title
Assessment of minimal residual disease using droplet digital PCR in cryopreserved ovarian tissue sections from pediatric and adolescent female cancer patients undergoing fertility preservation
Scientific Title:Acronym
Assessment of minimal residual disease using droplet digital PCR in cryopreserved ovarian tissue sections from pediatric and adolescent female cancer patients undergoing fertility preservation
Region
| Japan |
Condition
Condition
Leukemia, malignant lymphoma and other blood disorders, childhood cancer
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology | Pediatrics |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A novel PCR technique is used to detect malignant tumor cells present in ovarian tissue, allowing for the selection of safe ovarian tissue for transplantation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We will verify whether the results of the PCR (ddPCR: droplet digital PCR) used in this study are consistent with the following: 1. Histopathological test results, 2. Molecular test results, 3. Presence or absence of tumor recurrence after disease treatment, and 4. Life prognosis.
Tests 1 and 2 are tests to check for the presence or absence of minimal residual disease (MRD) in ovarian tissue.
Key secondary outcomes
Based on the verification results obtained using ddPCR, ovarian tissue will be transplanted into SCID mice to evaluate whether tumors are formed.
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with diseases such as leukemia, blood disorders, or malignant tumors.
Patients for whom informed consent has been obtained from the patient or guardian.
Key exclusion criteria
Cases where consent cannot be obtained.
Other cases that the research director or ethics committee deems inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Keino |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hematology/Oncology
Zip code
232-8555
Address
2-138-4 Mutsukawa, Minami-Ku, Minami-ku, Yokohama city, Kanagawa, JAPAN
TEL
045-711-2351
d2keino@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Keino |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hematology/Oncology
Zip code
232-8555
Address
2-138-4 Mutsukawa, Minami-Ku, Minami-ku, Yokohama city, Kanagawa, JAPAN
TEL
045-711-2351
Homepage URL
https://kcmc.kanagawa-pho.jp/
d2keino@marianna-u.ac.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kanagawa Children's Medical Center
Address
2-138-4 Mutsukawa, Minami-Ku, Minami-ku, Yokohama city, Kanagawa, JAPAN
Tel
045-711-2351
d2keino@marianna-u.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
神奈川県立こども医療センター（神奈川県）、聖マリアンナ医科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics: age at time of ovarian tissue cryopreservation, date of birth, and presence or absence of ovarian infiltration on imaging before treatment.
Cancer disease information: diagnosis, presence or absence of chimeric gene, histopathological diagnosis, and stage.
Treatment information: presence or absence of chemotherapy before ovarian tissue cryopreservation, and type of chemotherapy administered.
Management information
Registered date
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067524
