UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045411 |
|---|---|
| Receipt number | R000051838 |
| Scientific Title | Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2025/03/11 20:20:54 |
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Basic information
Public title
Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion
Acronym
Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion
Scientific Title
Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion
Scientific Title:Acronym
Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study were to investigate the relationships of circulating tumor DNA (ctDNA) with tumor size and clinicopathological features in individuals with distant metastases from colorectal cancer and to determine the factors affecting the leakage of ctDNA into the blood. Additionally, we expect that measurement of mutations using next-generation sequencing and analysis of exosome-derived DNA and RNA will contribute to improving the precision of genetic tests using blood samples and the establishment of advanced testing technologies.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between pathological features and status of ctDNA detection in tissue samples of metastatic organs
Correlations between ctDNA detection status and clinical information, including radiological images
Significance of exosome analysis in cases in which ctDNA is difficult to detect
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
Eligibility criteria for the prospective cohort
1. Patients with colorectal cancer diagnosed with lung or liver metastases
2. Computed tomography (CT) scan performed within 60 days of registration
3. Patients who plan to undergo resection of lung metastasis with curative intent
4. Resection with curative intent is performed to remove primary lesions
5. 20 years or older at the time of obtaining informed consent
6. Provides written informed consent to participate in this study
Eligibility criteria for the retrospective cohort
1. Patients with colorectal cancer diagnosed with lung or liver metastases
2. Prior to biobank blood sampling, resection with curative intent was performed to remove the primary lesion
3. Interval from biobank blood sampling to excision of metastatic sites was less than 90 days
4. Those who have undergone curative resection of metastasis to other organs during the study period*
*Two-stage resection is acceptable in patients who have undergone curative resection.
5. Comprehensive consent for the use of surplus medical samples was obtained from the National Cancer Center.
Key exclusion criteria
Exclusion criteria for the prospective cohort
1. Active overlapping cancers noted at the time of curative resection.
However, patients with a recurrence-free period of at least 5 years; those with basal cell carcinoma or spinous cell carcinoma of the skin that was eventually cured after receiving local treatment; and those with superficial bladder cancer, cervical cancer, carcinoma in situ, intramucosal cancer (that can be treated endoscopically), and nonmetastatic prostate cancer (that does not require systematic treatment) can be registered.
2. Pre-operative treatment (chemotherapy, radiation therapy, immunotherapy) is administered or planned prior to metastasis resection
Exclusion criteria for the retrospective cohort
1. Active overlapping cancers noted at the time of curative resection.
*However, patients with a recurrence-free period of at least 5 years or those with basal cell carcinoma or spinous cell carcinoma of the skin that was eventually cured by local treatment, superficial bladder cancer, cervical cancer, carcinoma in situ (that can be treated endoscopically), and nonmetastatic prostate cancer (that does not require systematic treatment) can be registered.
2. Pre-operative treatment (chemotherapy, radiation therapy, immunotherapy) was administered prior to the curative resection of metastases.
**Adjuvant chemotherapy administered prior to the appearance of metastases is acceptable.
Target sample size
100
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 and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7333-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yukami |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7333-1111
Homepage URL
hyukami@east.ncc.go.jp
Sponsor or person
Institute
National Research and Development Agency, National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
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
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irst@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
| 2021 | 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
46
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
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aims of this study were to investigate the relationships of circulating tumor DNA (ctDNA) with tumor size and clinicopathological features in individuals with distant metastases from colorectal cancer and to determine the factors affecting the leakage of ctDNA into the blood. Additionally, we expect that measurement of mutations using next-generation sequencing and analysis of exosome-derived DNA and RNA will contribute to improving the precision of genetic tests using blood samples and the establishment of advanced testing technologies.
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051838
