UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040151 |
|---|---|
| Receipt number | R000045780 |
| Scientific Title | Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2020/04/14 07:49:37 |
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Basic information
Public title
Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer
Acronym
COSMOS-VOLTAGE
Scientific Title
Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer
Scientific Title:Acronym
COSMOS-VOLTAGE
Region
| Japan |
Condition
Condition
Resectable Locally Advanced Rectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate ctDNA LUNAR assay for patients who will start preoperative chemoradiotherapy intending to enroll the VOLTAGE study
Basic objectives2
Others
Basic objectives -Others
To evaluate the correlation between microbiome and the efficacies of the VOLTAGE study in patients who will start preoperative chemoradiotherapy intending to enroll the VOLTAGE study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive rate of LUNAR assay
Key secondary outcomes
Correlation between post-operative positive rate of LUNAR assay and prognosis
Correlation between status of LUNAR assay and efficacies of VOLTAGE treatment
Concordance of gene status between LUNAR assay and tumor tissue
Concordance of MSI status between LUNAR assay and tumor tissue
Correlation between microbiome and the efficacies of the VOLTAGE study
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with resectable LARC who will participate in VOLTAGE cohort D
2. Agree to receive preoperative chemoradiation
3. Age of >= 20 to < 80 years at time of informed consent
4. Willing to provide blood samples per protocol.
5. Has given written consent
Key exclusion criteria
1. Pregnant.
2. Judged by the study doctor to be ineligible for the study for any other reason.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
Naitonal Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
yoshinak@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL
052-764-6111
Homepage URL
hbando@aichi-cc.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
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
| 2020 | Year | 04 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045780
| Research Plan | |
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| 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 |
