UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061318 |
|---|---|
| Receipt number | R000070156 |
| Scientific Title | A prospective multicenter observational study investigating the association between the improvement rate of preoperative anemia and treatment outcomes in colorectal cancer |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/20 11:27:14 |
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Basic information
Public title
A prospective multicenter observational study investigating the association between the improvement rate of preoperative anemia and treatment outcomes in colorectal cancer
Acronym
IRON study
Scientific Title
A prospective multicenter observational study investigating the association between the improvement rate of preoperative anemia and treatment outcomes in colorectal cancer
Scientific Title:Acronym
IRON study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify, in colorectal cancer patients scheduled for primary tumor resection who present with anemia at the initial visit, the real-world status of preoperative anemia management in routine clinical practice, as well as the association between changes in hemoglobin levels after treatment and perioperative outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in hemoglobin (Hb): the change in Hb level from the start of treatment to the time of surgery.
Key secondary outcomes
Perioperative blood transfusion volume
Incidence of perioperative complications
Changes in laboratory values (ferritin, transferrin saturation [TSAT], and C-reactive protein [CRP])
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with histologically confirmed colorectal cancer
Patients scheduled for primary tumor resection
Patients whose hemoglobin level at the initial visit meets the following criteria:
Male: < 13.0 g/dL
Female: < 12.0 g/dL
Key exclusion criteria
Patients undergoing emergency surgery with primary tumor resection
Patients with severe anemia requiring blood transfusion at the initial visit
Patients with contraindications to iron therapy (e.g., hepatic or renal dysfunction, myelodysplastic syndromes [MDS], hemochromatosis, thalassemia, hemolytic anemia)
Patients who have already received preoperative anemia treatment (blood transfusion within 1 month or erythropoietin use within 3 months)
Patients deemed unsuitable for participation in this study by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Numata |
Organization
Yokohama City University Medical Center
Division name
Department of Gastroenterological Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL
045-261-5656
numata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Nukada |
Organization
Yokohama City University Medical Center
Division name
Department of Gastroenterological Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL
045-261-5656
Homepage URL
nukada.sug.df@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-787-2800
ynext@yokohama-cu.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
| 2026 | Year | 04 | Month | 20 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Observation and Assessment Items]
Baseline characteristics: age, sex, height, weight, past medical history, comorbidities, performance status (PS), preoperative treatment information
Blood tests (at initial visit and preoperatively):
Hematological tests: lymphocyte count, hemoglobin level
Biochemical tests: serum iron, ferritin, total iron-binding capacity (TIBC), serum albumin, prealbumin, C-reactive protein (CRP)
Tumor markers: carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9) [at initial visit only]
Anemia treatment information: use of intravenous iron, oral iron, and/or blood transfusion; start date; dosage
Perioperative schedule: waiting period (number of days from initial visit to surgery)
Surgical information: date of surgery, name of surgeon, name of assistant, intraoperative blood loss, operative time, conversion to open surgery, reason for conversion, surgical procedure, surgical approach (laparoscopic/robotic), extent of central lymph node dissection, combined resection of other organs, name of resected organs, method of blood flow assessment, anastomotic technique, creation of diverting stoma, lateral lymph node dissection, distance from the anastomosis to the anal verge, postoperative complications, complication grade, date of discharge
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070156
