UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043890 |
|---|---|
| Receipt number | R000050119 |
| Scientific Title | Biomarker study for patients with metastatic colorectal cancer treated with anti-angiogenic agent using liquid biopsy |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2022/04/13 19:16:51 |
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Basic information
Public title
Biomarker study for patients with metastatic colorectal cancer treated with anti-angiogenic agent using liquid biopsy
Acronym
AAA-liquid
Scientific Title
Biomarker study for patients with metastatic colorectal cancer treated with anti-angiogenic agent using liquid biopsy
Scientific Title:Acronym
AAA-liquid
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To verify whether the presence or absence of mutations in RAS, BRAF, PIC3CA, EGFR, etc. in liquid biopsy before second-line chemotherapy for unresectable colorectal cancer is useful for predicting the efficacy of chemotherapy and the prognosis of colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Searching for biomarkers to predict the efficacy of anticancer chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of RAS, BRAF, PIC3CA, and EGFR gene mutations in liquid biopsy with chemotherapy efficacy and prognosis of colorectal cancer
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically diagnosed as colorectal cancer
Having distant metastases, at least one of which is unresectable
The longest axis of metastatic lesion is more than 2cm in diameter.
First line chemotherapy for distant metastases has been completed
Age between 20 and 80 years at the date of enrollment
ECOG PS 0-1
Having measurable metastatic lesion.
Oral intake is possible.
Expected to survive for at least 3 months
Preservation of major organ function with all of the following on examination within 2 weeks prior to enrollment
White blood cell count: 3,500/mm3or higher
Neutrophil count: 1,500/mm3 or higher
Platelet count: 75,000/mm3 or higher
Hemoglobin: 8.0g/dl or higher
AST and ALT: Less than 2.5 times the upper limit of the institutional standard
Total bilirubin: 1.5 mg/dl or less
Creatinine: 1.5mg/dl or less
Infection: No active infection suspected.
Diarrhea, other non-hematological toxicity: less than Grade 1(Excluding hair loss, dysgeusia, hyperpigmentation, and symptoms associated with the primary disease)
The patient's free written consent to participate in this study has been obtained after receiving sufficient explanation and understanding.
Key exclusion criteria
Having UGT1A1*6 homo, UGT1A1*28 homo, and UGT1A1*6*28 double hetero
Contraindicated for anti-VEGF inhibitor.
Previous treatment with irinotecan
Previous treatment with ramucirumab or aflibercept
History of severe drug hypersensitivity
Pregnant women or women who may become pregnant.
Men whose partners wish to become pregnant.
Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
Patients with pleural effusion or ascites requiring treatment
Patients with peritoneal dissemination that is considered likely to cause intestinal obstruction.
Active multiple cancers.
Significant ECG abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris, etc.)
Having brain metastases.
Patients with active multiple cancers with a disease-free interval of less than 5 years (cured basal cell carcinoma of the skin and cervical cancer, or gastric cancer, esophageal cancer, and colorectal pM cancer confirmed to be cured by endoscopic mucosal resection may be enrolled.
FDG-PET scan is not necessary, but bone metastasis should not be detected.
The physician in charge considers the patient unsuitable for participation in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamada |
Organization
Nippon Medical School Hospital
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
y-tak@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Sonoda |
Organization
Nippon Medical School Hospital
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
Homepage URL
hiromichi-sonoda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical Scool
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
+81-3-3822-2131
hiromichi-sonoda@nms.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
| 2021 | Year | 04 | Month | 12 | 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
| 2021 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050119
