UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053642 |
|---|---|
| Receipt number | R000061226 |
| Scientific Title | A retrospective observational study of molecular profiling in secondary cancer patients |
| Date of disclosure of the study information | 2024/02/19 |
| Last modified on | 2024/02/19 04:41:51 |
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Basic information
Public title
A retrospective observational study of molecular profiling in secondary cancer patients
Acronym
A retrospective observational study of molecular profiling in secondary cancer patients
Scientific Title
A retrospective observational study of molecular profiling in secondary cancer patients
Scientific Title:Acronym
A retrospective observational study of molecular profiling in secondary cancer patients
Region
| Japan |
Condition
Condition
secondary cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
A database of cases of second cancers caused by previous chemotherapy, cytotoxic anticancer drugs, molecular targeted therapies, and immune checkpoint inhibitors will be developed. The tumors' molecular biological characteristics will be analyzed to propose treatment strategies for second cancer development.
Basic objectives2
Others
Basic objectives -Others
It may be possible to choose the best treatment by analyzing gene expression and genetic abnormalities in secondary cancer cases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Combined genotype and immune phenotype, biomarkers can classify the tumor immune microenvironment of secondary carcinoma cases, identify patients who will benefit from immune checkpoint inhibitors, and evaluate differences in therapeutic efficacy.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must be at least 20 years of age at the time of consent.
Patients who have received systemic chemotherapy (including cytotoxic chemotherapy, molecular targeted therapy, and immune checkpoint inhibitors) in the past
Patients diagnosed with a second cancer
Patients who can provide tumor tissue.
Cases in which Informed Consent for this study has been obtained (except for cases in which the patient has already died or is unable to give Informed Consent due to medical conditions, etc.).
Key exclusion criteria
No specific exclusion criteria are set.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
5898511
Address
377-2 Ohno-higashi, Osaka-Sayama City, Osaka
TEL
0723660221
takahama_t@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Takahama |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
5898511
Address
377-2 Ohno-higashi, Osaka-Sayama City, Osaka
TEL
0723660221
Homepage URL
takahama_t@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai university faculty of medicine of Ethics Committe
Address
377-2 Ohonohigashi Osaka-sayama city Osaka Japan
Tel
072-366-0221
zizen@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
| 2024 | Year | 02 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Please extract clinical information from the medical record and ensure it is accurately recorded in the CRF. If any stored specimens, such as tumor tissue, are available, immunohistochemistry should be performed as required. It is important to note that these clinical details and specimens have already been collected during general practice and do not need to be newly gathered for this study.
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
