UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049867 |
|---|---|
| Receipt number | R000056796 |
| Scientific Title | Multicenter study to characterize the molecular genetic features of exceptional response to radiotherapy |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2024/06/24 10:36:47 |
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Basic information
Public title
Multicenter study to characterize the molecular genetic features of exceptional response to radiotherapy
Acronym
Multicenter study on exceptional response to radiotherapy
Scientific Title
Multicenter study to characterize the molecular genetic features of exceptional response to radiotherapy
Scientific Title:Acronym
Multicenter study on exceptional response to radiotherapy
Region
| Japan |
Condition
Condition
Cancers treated with radiotherapy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To retrospectively characterize the molecular genetic features of exceptional response to radiotherapy by a multicenter study
Basic objectives2
Others
Basic objectives -Others
To identify genetic alterations in tumor tissues such as somatic mutations, copy number alterations, aberrant expression, and structural variants.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of genetic alterations in tumor tissues such as somatic mutations, copy number alterations, aberrant expression, and structural variants
Key secondary outcomes
Altered gene pathways, tumor immune response, germline mutations, overall survival, progression-free survival, local progression-free survival, duration of response
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 who meet all of the following criteria 1) to 5)
1) Cancer patients who received radiotherapy at the collaborating institutions between January 2012 and March 2022.
2) Patients who showed an exceptional response to radiotherapy that deviated from the expected radiation dose-effect relationship.
3) Patients who did not receive any drugs to reduce the size of the cancer during radiotherapy.
4) Patients who are 20 years of age or older at the time of radiotherapy.
5) Patients with one or more of the following existing samples available for genetic analysis or histopathological evaluation:
A) Excess tumor tissue samples collected for diagnosis.
B) Surplus tumor tissue samples obtained at surgery.
C) Excess tumor tissue samples stored in the biobank of each institution, for which consent for the use of biobank samples has been obtained from the patient.
Key exclusion criteria
1) Patients with a history of prior radiotherapy for lesions exhibiting exceptional response.
2) Patients unsuitable for the study judged by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center
Division name
Hospital East, Department of Radiation Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
exceptional-responder-jimukyoku@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hidenari |
| Middle name | |
| Last name | Hirata |
Organization
National Cancer Center
Division name
Hospital East, Department of Radiation Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
exceptional-responder-jimukyoku@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
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
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2022 | Year | 12 | Month | 22 | 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
31
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design:
Translational Research Study
The analysis will be conducted mainly using existing samples and information. However, for subjects who are attending each collaborating institution at the time of the study, new samples collected from obtaining consent to the end of the study will also be included in the analysis.
Observation and examination items:
DNA analysis, RNA analysis, histopathological evaluation, existing information obtained from the patient's medical record as follows: patient background (age, gender, cancer type, primary histology, stage, complications, birth date, etc.) test results (blood tests, images, histopathology, genetic alterations in tumor tissues identified in the clinical course, genetic test results (germline BRCA1, BRCA2, MEN1, RET, and RB1 profiling performed by insurance, cDNA and amino acid sequence information of the identified variants and their pathological significance, etc.), details of the treatment course (previous treatment history, radiation dose, radiation field, concomitant therapy, treatment start date, treatment end date, best overall response, date of confirmation of disease progression, etc.), and treatment results (duration of treatment response, the last date confirmed alive, date of death, etc.)
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056796
