UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049066 |
|---|---|
| Receipt number | R000055900 |
| Scientific Title | Research on genetic profiling and its clinical significance using clinical specimens from cancer patients |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2022/09/29 18:27:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on genetic profiling and its clinical significance using clinical specimens from cancer patients
Acronym
CONDUCTOR study
Scientific Title
Research on genetic profiling and its clinical significance using clinical specimens from cancer patients
Scientific Title:Acronym
CONDUCTOR study
Region
| Japan |
Condition
Condition
Malignant Tumors
There are no restrictions on the type of cancer, although breast cancer, lung cancer, and gastrointestinal cancer are covered.
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The main purpose is to implement "whole genome analysis, etc." based on the "Whole Genome Analysis, etc. Action Plan" promoted by the government, to establish a system to safely and smoothly implement "whole genome analysis, etc." in Japan for use in medical treatment, research, drug discovery, etc., and to establish a system to appropriately utilize the results, etc. in patient care after interpretation and examination of analysis results by experts.
Basic objectives2
Others
Basic objectives -Others
In addition, genetic, gene expression, and protein expression analyses of tumor and non-tumor tissues of cancer patients will be performed to examine the relationship between the therapeutic efficacy and toxicity of antineoplastic drugs. We will also examine the relationship between the results of the analyses in this study and clinicopathological and molecular biological characteristics, as well as therapeutic efficacy and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In order to deliver high quality medical care to the public and to "conquer cancer" in the future, we will strategically accumulate the results of whole genome analysis and other analyses, and promote their use in research and drug discovery. In addition, genetic profiling using clinical specimens and its clinical significance will be discussed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
4.1 Eligibility Criteria
1. be at least 18 years of age at the time of consent
2. cancer patients who are being or may be considered for treatment with antineoplastic agents at the participating institution
3) Patients for whom one or more of the following samples, which can be analyzed genetically, can be obtained
i. Tumor tissue
(i) Surplus biopsy specimens (frozen specimens and formalin-embedded tissues) collected during medical treatment
(ii) Surplus specimens of surgical specimens (formalin-embedded tissue)
(iii) Specimens collected in clinical trials* related to this study (frozen specimens)
ii. Non-tumor tissue
(iv) Specimens collected in clinical trials* related to this study (frozen specimens)
(v) New peripheral blood samples (up to 20 mL) to be collected for this study
(*) Relevant clinical trials include the ENSEMBLE study, a clinical trial of perioperative treatment of rectal cancer. 4.
Written consent for participation in this study has been obtained.
Key exclusion criteria
1. the physician in charge determines that the subject is not suitable for enrollment in this study, taking into consideration the subject's physical and mental condition, etc.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL
0471331111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ando |
Organization
National Cancer Center Hospital East
Division name
Department of Colorectal Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL
0471331111
Homepage URL
kandou@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Cancer Center Institutional Review Board
Address
5-1-1, tsukiji, tyuo-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 | 09 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055900
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
