UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036749 |
|---|---|
| Receipt number | R000041394 |
| Scientific Title | Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2023/02/09 14:14:10 |
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Basic information
Public title
Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
Acronym
MONSTAR-SCREEN
Scientific Title
Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
Scientific Title:Acronym
SCRUM-Japan MONSTAR-SCREEN
Region
| Japan |
Condition
Condition
Advanced Solid Malignancies
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze circulating tumor DNA (ctDNA) and feces of patients with advanced solid malignancies over time to profile and monitor cancer-related genomic alterations and the gut microbiome.
Basic objectives2
Others
Basic objectives -Others
To characterize the relationship of these profiles to clinical pathology, the clinical course of the disease (e.g., treatment history, response rate, progression-free survival, time to treatment failure), and cancer-related genomic alterations in tumor tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profiles of ctDNA cancer-related genomic alterations and the gut microbiome
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Is at least 16 years of age at the time of consent.
2. Has a histopathologically confirmed solid malignancy.
3. Has unresectable lesions.
4. Has undergone or is scheduled to undergo a comprehensive genomic profile that uses tumor tissue.
5. Has personally given consent in writing to participate in this study.
6. Satisfies either i or ii below:
i. Has not undergone chemotherapy.
ii. Was found to have progressed in diagnostic imaging performed while receiving chemotherapy or assessed by the investigator of likely having clinical progressive disease and has not yet begun the subsequent chemotherapy.
7. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
8. Results of latest laboratory tests performed within 21 days of enrollment satisfy all of the following .
9. Has no serious comorbidities.
10. Has a remaining life expectancy of at least 12 weeks after the day of enrollment.
11. Intends to receive study treatment based on the results of genomic alteration analysis.
12. Meets the description of one of Cohorts A to D below:
Cohort A: Patients with certain solid malignancies who have not undergone chemotherapy
Patients who have not yet undergone initial chemotherapy for an advanced solid malignancy specified.
Cohort B: Patients with certain genomic alterations
Patients found to have a genomic alteration specified in Reference Material in comprehensive genomic profile, the GOZILA Study, or FoundationOne Liquid of the present study and are scheduled to undergo chemotherapy as their subsequent chemotherapy.
Cohort C: Patients scheduled to undergo treatment with an immune checkpoint inhibitor
Patients whose next scheduled treatment is an immune checkpoint inhibitor.
Cohort D: Patients scheduled to undergo treatment with certain molecular targeted drugs
Patients whose next scheduled treatment is chemotherapy with a molecular targeted drug able to cause clonal evolution.
Key exclusion criteria
1. Has previously undergone an autologous stem cell transplant or organ transplant.
2. Has a history of other malignancies.
3. If found by the investigator to be unsuited to participate in the study.
Target sample size
2300
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
04-7133-111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
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
04-7133-111
Homepage URL
yoshinak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
SCRUM Japan
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 Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-111
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
| 2019 | Year | 05 | Month | 15 | 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
2224
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
| 2019 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
Target population:the patients who meet the selection criteria until March 31 2023 from research permit date
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041394
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