UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057128 |
|---|---|
| Receipt number | R000065299 |
| Scientific Title | Clinical utility of circulating tumor DNA to detect early tumor recurrence after surgery in patients with radically resectable liver metastases from colorectal cancer: a single institute prospective observational study |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/25 16:41:10 |
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Basic information
Public title
A study to determine whether detection of tumor-derived DNA in the blood of patients with colorectal cancer with liver metastases can be useful for early detection of recurrence of the disease
Acronym
CASSIOPEIA study
Scientific Title
Clinical utility of circulating tumor DNA to detect early tumor recurrence after surgery in patients with radically resectable liver metastases from colorectal cancer: a single institute prospective observational study
Scientific Title:Acronym
CASSIOPEIA study
Region
| Japan |
Condition
Condition
patients with resectable liver metastases from colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The CASSIOPEIA study aims to evaluate the efficacy of plasma-only ctDNA assays for detecting recurrence early in patients with CRC and liver-only metastases post-curative resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is the interval between the detection of ctDNA positivity and the clinical diagnosis of recurrence.
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
1. Histological Diagnosis: Histopathologically confirmed adenocarcinoma of colorectal cancer.
2. Primary Tumor Location and Resection: The primary tumor is located in the colon (cecum, colon, sigmoid rectum) or rectum and has been resected. Appendiceal and anal canal cancers are excluded.
3. Liver Metastases: No distant metastases other than liver metastases, and curative hepatectomy is planned for the first time. Cases involving systemic chemotherapy enabling curative liver resection (conversion therapy) are also eligible.
4. Age: 20 years or older at the time of consent acquisition.
5. Performance Status: ECOG PS of 0 or 1.
6. Informed Consent: Written informed consent for study participation was obtained from the patient.
Key exclusion criteria
1. Active Double Cancer: Active overlapping cancers at the time of hepatectomy. Exceptions include: (a) relapse-free period of more than 5 years, (b) localized cancers cured through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, ductal carcinoma in situ, or mucosal carcinoma), or (c) non-metastatic prostate cancer not requiring systemic treatment.
2. Pregnancy or Breastfeeding: Pregnancy or lactation at the time of the study.
3. Serious Complications: Patients with severe comorbidities that could affect the safety or proper implementation of the study.
4. Viral Infections: Positive for HBs antigen, HCV antibody, or HIV antibody.
5. Medical Inappropriateness: Deemed unsuitable for the study by the attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Osaka General Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
558-8558
Address
3-1-56 Mandaihigashi, Sumiyoshi-ku, Osaka City, Osaka 558-8558, Japan
TEL
06-6692-1201
inoue_medical@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
Osaka General Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
558-8558
Address
3-1-56 Mandaihigashi, Sumiyoshi-ku, Osaka City, Osaka 558-8558, Japan
TEL
06-6692-1201
Homepage URL
inoue_medical@yahoo.co.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medical Center
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
Osaka General Medical Center
Address
3-1-56 Mandaihigashi, Sumiyoshi-ku, Osaka City, Osaka 558-8558, Japan
Tel
06-6692-1201
inoue_medical@yahoo.co.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
| 2025 | Year | 03 | 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
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
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data, including patient demographics, treatment details, and outcomes, will be collected in a secure, anonymized database. All ctDNA results will remain blinded to treating physicians throughout the study, preventing potential bias in clinical decision-making and ensuring the validity of the study outcomes. Plasma samples will be processed and analyzed at a centralized laboratory to ensure consistency, with stringent quality control measures implemented to maintain data integrity. These measures include duplicate analyses for key samples, standardized protocols for DNA extraction and sequencing, and regular calibration of laboratory equipment to ensure reproducibility and reliability.
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065299
