UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036681 |
|---|---|
| Receipt number | R000041793 |
| Scientific Title | A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial) |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2020/05/08 09:03:15 |
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Basic information
Public title
A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial)
Acronym
A biomarker study to analyze ctDNA/CTC in gastrointestinal cancers (Valor trial)
Scientific Title
A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial)
Scientific Title:Acronym
A biomarker study to analyze ctDNA/CTC in gastrointestinal cancers (Valor trial)
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The primary aim is to evaluate genomic markers and concordance with ctDNA and CTC in patients with metastatic GI cancers. Then, this study approaches to assess which biomarkers can predict clinical outcome more accurately.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance in genomic profiling between ctDNA and CTC
Key secondary outcomes
1. Association between genetic status in ctDNA and clinical outcomes
2. Association between genetic status in CTC and clinical outcome
3. Compare genetic change between ctDNA and CTC in mCRC patients with RAS wild-type tumors treated with anti-EGFR mAb.
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
(1) Patients with histologically confirmed diagnosis of GI cancers (esophageal, gastric, pancreatic, colorectal cancers)
(2) Patients who receive systemic chemotherapy in first- or second-lines / Patients with RAS wild-type mCRC treated with anti-EGFR antibody at any-lines
(3) ECOG PS 0 or 1
(4) Patients agree with blood draw at several times for ctDNA and CTC analyses
Key exclusion criteria
(1) Patients who are regarded as inadequate for study enrollment by investigators.
(2) Patients do not agree with use of samples
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
y.suna0825@gmail.com
Public contact
Name of contact person
| 1st name | Shinko |
| Middle name | |
| Last name | Hanaki |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
Homepage URL
rinshoushuyougaku-004@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinomics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine IRB
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
Tel
044-976-9518
nota@marianna-u.ac.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
| 2019 | Year | 05 | Month | 08 | 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
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registering
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041793
