UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029371 |
|---|---|
| Receipt number | R000033566 |
| Scientific Title | A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node |
| Date of disclosure of the study information | 2017/10/02 |
| Last modified on | 2023/09/17 17:10:30 |
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Basic information
Public title
A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Acronym
A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Scientific Title
A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Scientific Title:Acronym
A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Region
| Japan |
Condition
Condition
colon and rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinicopathological features and prognosis of ovarian metastasis, metastasis to inguinal lymph nodes.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
ovarian metastasis:3 years overall survival
metastasis to inguinal lymph nodes:5 years overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ovarian metastasis
1.The case of Ovarian metastasis diagnosed between 1 January 2000 and 31 December 2014.
2.The primary tumor was histologically diagnosed as adenocarcinoma of colon and rectal cancer.
Inguinal lymph node metastasis
1.The case of lymph node metastasis diagnosed between 1 January 1997 and 31 December 2011.
2.The primary tumor is histologically diagnosed as rectal cancer and anal canal cancer.
Key exclusion criteria
Ovarian metastasis
1.A case of ovariectomy due to other diseases
2.Primary tumor is appendice carcinoma
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Kagawa |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of colon and rectal cancer
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
Homepage URL
http://jsccr.jp/project/proj_ovary.html
h.kagawa@scchr.jp
Sponsor or person
Institute
Japanese society for cancer of colon and rectum
Institute
Department
Personal name
Funding Source
Organization
Japanese society for cancer of colon and rectum
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese society for cancer of colon and rectum
Address
3 bancho, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-8697
jsccr@secretariat.ne.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
静岡県立静岡がんセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/ags3.12740
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/ags3.12740
Number of participants that the trial has enrolled
300
Results
The prognosis after curative resection for solitary ovarian metastases was shown to be relatively favorable as Stage IV colorectal cancer. Resection of ovarian metastases, not only curative resection but also noncurative resection, confers a survival benefit. Prognostic factors were large ovarian metastases, bilateral ovarian metastases, the presence of extraovarian metastases, and remnant ovarian metastases.
Results date posted
| 2023 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included patients diagnosed with ovarian metastasis from CRC between 2000 and 2014 from the 20 Japanese institutions. Primary CRC was histologically diagnosed as adenocarcinoma. The diagnosis of ovarian metastasis was based on histological findings in cases that involved ovarian resection, or imaging findings (e.g. computed tomography, positron emission tomography, and magnetic resonance imaging) in cases that did not resect ovarian metastasis. Cases were excluded if they involved oophorectomy for other diseases, the previous treatment of other pelvic malignancies, or appendix cancer.
Participant flow
Resection of the ovarian metastasis was performed in 252 patients (85.1%), with surgeries classified as curative resection in 121 cases (40.9%) and noncurative resection in 128 cases (43.2%).
Adverse events
Not applicable
Outcome measures
The primary outcome assessed was survival after diagnosis of the ovarian metastasis, which was evaluated according to curative resection, noncurative resection, or nonresection of the ovarian metastasis. The secondary outcomes assessed included prognostic factors for ovarian metastasis in CRC, the clinicopathological characteristics of ovarian metastasis from CRC, and survival of solitary ovarian metastases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center retrospective cohort study
Management information
Registered date
| 2017 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033566
