UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059613 |
|---|---|
| Receipt number | R000068106 |
| Scientific Title | A Multi-institutional Prospective Observational Study on Bowel Resection in Patients with Ovarian, Fallopian Tube, or Peritoneal Cancer |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/11/01 08:31:36 |
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Basic information
Public title
A study to investigate outcomes in patients with ovarian, fallopian tube, or peritoneal cancer who underwent bowel surgery
Acronym
Ovarian Cancer Bowel Resection Study
Scientific Title
A Multi-institutional Prospective Observational Study on Bowel Resection in Patients with Ovarian, Fallopian Tube, or Peritoneal Cancer
Scientific Title:Acronym
Ovarian Cancer Bowel Resection Study
Region
| Japan |
Condition
Condition
Stage II-IV ovarian, fallopian tube, or peritoneal cancer
Classification by specialty
| Gastrointestinal surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To prospectively investigate the clinical significance of mesenteric lymph node metastasis in patients undergoing rectosigmoid resection for ovarian, fallopian tube, or peritoneal cancer
Basic objectives2
Others
Basic objectives -Others
Clinical significance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Rate of rectosigmoid resection
2. Frequency of mesenteric lymph node metastasis in patients who underwent rectosigmoid resection
Key secondary outcomes
1. Clinicopathological factors associated with mesenteric lymph node metastasis
2. Progression-free survival (PFS) and overall survival (OS) according to mesenteric lymph node metastasis status
3. Predictive factors for rectosigmoid resection in Stage II-IV ovarian, fallopian tube, or peritoneal cancer
4. Stoma creation and closure rates in rectosigmoid resection
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
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients who underwent surgery at Niigata University Medical and Dental Hospital or Niigata Cancer Center Hospital
2. Age: 18-100 years
3. Diagnosed with Stage II-IV ovarian, fallopian tube, or peritoneal cancer
4. Including patients who underwent diagnostic laparoscopy only
5. Provided written informed consent
Key exclusion criteria
Cases judged inappropriate for study registration by the principal investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Shimada |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
025-227-2228
shimaday@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Shimada |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
025-227-2228
Homepage URL
shimaday@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2025 | Year | 11 | 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
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a non-interventional observational study, follow-up methods are not mandated. However, postoperative follow-up including chest, abdominal, and pelvic CT scans every 3-6 months is recommended. Tumor response evaluation according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 (Japanese translation JCOG version 1.0) is recommended. All examinations are performed within standard clinical practice.
Management information
Registered date
| 2025 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068106
