UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050428 |
|---|---|
| Receipt number | R000057431 |
| Scientific Title | A highly-sensitive cell free DNA assay in gastrointestinal tumors - A prospective observational study |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/08/19 11:07:08 |
* 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
A highly-sensitive cell free DNA assay in gastrointestinal tumors - A prospective observational study
Acronym
An observational study of highly-sensitive cell free DNA assay
Scientific Title
A highly-sensitive cell free DNA assay in gastrointestinal tumors - A prospective observational study
Scientific Title:Acronym
An observational study of highly-sensitive cell free DNA assay
Region
| Japan |
Condition
Condition
Gastrointestinal malignant tumors
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective is to explore the clinical utility of a novel cell free DNA (cfDNA) assay for tumor detection and quantification in patients with gastrointestinal malignancies.
Basic objectives2
Others
Basic objectives -Others
The objective is to explore the clinical utility of a novel cell free DNA (cfDNA) assay for tumor detection and quantification in patients with gastrointestinal malignancies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cfDNA dynamics (Percentage of cfDNA detected at each test time point and its trend)
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
1) Written consent has been obtained from the patient after a full explanation of the study content has been given prior to enrollment in the study.
2) Patients must be at least 18 years of age at the time of enrollment.
3) Patients must have a primary malignant tumor of the gastrointestinal tract.
4) Patients are scheduled to receive either systemic drug therapy, radiation therapy, or surgery. (Patients on systemic drug therapy can be enrolled after progression of prior therapy and before initiation of the next therapy.)
Key exclusion criteria
1) The patient has active overlapping cancers (concurrent overlapping/multiple cancers).
2) Other conditions deemed inappropriate by the physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
4648681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
h.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
Homepage URL
h.taniguchi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Network
Institute
Department
Personal name
Funding Source
Organization
MEDICAL and BIOLOGICAL LABORATORIES CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi, Japan
Tel
052-762-6111
irb@aichi-cc.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
| 2023 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be enrolled promptly after consent is obtained. It is anticipated that there may be more than one treatment line in this study, in which case re-enrollment will be conducted with the same patients. Blood samples will be collected prior to the start of treatment and every 4 weeks thereafter, or when imaging evaluations are performed. If another interventional study specifies the timing of blood sample collection, the sample will be collected at the timing specified in that study. Blood samples collected for this study will be pseudonomized at each site and sent to G&G Sciences, where they will be appropriately processed and cfDNA will be extracted. The cfDNA is then subjected to DNA strand length, copy number, and tumor-specific mutation analysis. The Biomedical Research Institute will summarize the results of the measurements obtained at G&G Science, the research contractor, and report them to the research office. The correlation between the transition of treatment effect and the transition of cfDNA will be analyzed. This is an exploratory study and will not use validation methods such as statistical tests.
Management information
Registered date
| 2023 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057431
