UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061815 |
|---|---|
| Receipt number | R000070736 |
| Scientific Title | Significance Evaluation of Early-stage Disease via Circulating Tumor Cell |
| Date of disclosure of the study information | 2026/06/06 |
| Last modified on | 2026/06/06 01:10:36 |
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Basic information
Public title
Significance Evaluation of Early-stage Disease via Circulating Tumor Cell
Acronym
SEED-CTC
Scientific Title
Significance Evaluation of Early-stage Disease via Circulating Tumor Cell
Scientific Title:Acronym
SEED-CTC
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of circulating tumor cell testing in early-stage colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Few studies have investigated the association between circulating tumor cells (CTCs) and early-stage colorectal cancer. If a relationship between changes in CTC counts and disease status can be confirmed, CTC testing may be expected to serve as a useful screening method in clinical practice.
This study aims to clarify the CTC positivity rate in early-stage colorectal cancer and to evaluate its utility in prognostic prediction, early detection of recurrence, and assessment of treatment response.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The CTC positivity rate in patients with early-stage colorectal cancer
Key secondary outcomes
The secondary endpoints include the associations between CTC status or CTC counts and clinicopathological factors, changes in CTC positivity rates and CTC counts before and after treatment, associations between CTC status and recurrence or prognosis, and the diagnostic performance of CTC testing.
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. Histologically diagnosed as tubular adenocarcinoma, either well-differentiated or moderately differentiated, by endoscopic biopsy of the primary colorectal cancer lesion.
2. The main tumor location is one of the following: cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, upper rectum, or lower rectum.
3. Diagnosed as cStage I disease, with a depth of invasion of cT1 to 2, based on comprehensive assessment including chest, abdominal, and pelvic CT with a slice thickness of 5 mm or less, and/or pelvic MRI.
4. No lymph node metastasis is detected.
5. No distant metastasis is detected.
6. No synchronous multiple cancers are detected based on comprehensive assessment using lower gastrointestinal endoscopy and imaging studies, including barium enema examination, abdominal/pelvic CT, or CT colonography. However, cTis or cT1a lesions, which are expected to be curatively resectable by endoscopic resection and in which the cancer is expected to remain within the submucosal layer with an invasion depth of less than 1,000 um, are not regarded as multiple cancers.
7. Age at registration is 20 years or older.
8. Performance status is 0 to 2 according to the ECOG criteria.
9. The patient is able to tolerate oral intake.
10. The patient has no history of rectal resection, excluding endoscopic resection, or pelvic radiotherapy, including treatment for other types of cancer.
11. For patients registered at Tochigi Cancer Center, enrollment is limited to cases in which consent to participate in the Tochigi Cancer Biobank has been obtained.
Key exclusion criteria
1. The patient has active synchronous or metachronous multiple cancers.
2. The patient has lymph node metastasis.
3. The patient has distant metastasis.
4. Patients undergoing additional surgical resection after endoscopic treatment are excluded.
5. The patient has an infection requiring systemic treatment.
6. The patient is undergoing hemodialysis or has renal dysfunction, defined as a serum creatinine level exceeding the normal range at each participating institution.
7. The patient is receiving continuous systemic administration, either oral or intravenous, of corticosteroids or other immunosuppressive agents.
8. The patient has poorly controlled diabetes mellitus.
9. The patient is positive for HIV antibodies.
10. The patient has interstitial pneumonia, pulmonary fibrosis, or both, as diagnosed by chest CT.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Toyota |
Organization
Tochigi Cancer Center
Division name
Department of Colorectal Surgery
Zip code
3200834
Address
Yonan4-9-13, Utsunomiya, Tochigi, JAPAN
TEL
028-658-5151
natoyota@tochigi-cc.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Toyota |
Organization
Tochigi Cancer Center
Division name
Department of Colorectal Surgery
Zip code
3200834
Address
Yonan4-9-13, Utsunomiya, Tochigi, JAPAN
TEL
028-658-5151
Homepage URL
natoyota@tochigi-cc.jp
Sponsor or person
Institute
Tochigi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Tokyo Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Cancer Center Institutional Review Board
Address
Yonan4-9-13, Utsunomiyam Tochigi, JAPAN
Tel
028-658-5151
contact@tochigi-cc.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
栃木県立がんセンター、NHO東京医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 06 | 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
10
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
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070736
