UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032645 |
|---|---|
| Receipt number | R000037224 |
| Scientific Title | Correlation between serum biomarkers, location of endometriosis lesion, and clinical presentation |
| Date of disclosure of the study information | 2018/05/19 |
| Last modified on | 2018/05/19 15:43:08 |
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Basic information
Public title
Correlation between serum biomarkers, location of endometriosis lesion, and clinical presentation
Acronym
Serume biomarkers in endometriosis
Scientific Title
Correlation between serum biomarkers, location of endometriosis lesion, and clinical presentation
Scientific Title:Acronym
Serume biomarkers in endometriosis
Region
| Europe |
Condition
Condition
Endometriosis
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the role of serum biomarkers, if any, to detect endometriosis locations and the correlation with clinical presentation
Basic objectives2
Others
Basic objectives -Others
Correlation between the raise of serum biomarkers according to specific sites where endometriosis lesions lie and clinical symptoms
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correspondence between serum biomarkers evaluated before surgery, clinical manifestations, and pelvic sites where endometriosis lesions are found at laparoscopy.
Key secondary outcomes
Clinical interpretation of each biomarker (Ca125, Ca 19.9, Ca 15.3) in endometriosis
Base
Study type
Others,meta-analysis etc
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
Evidence (at ultrasound and/or MRI) or suspect of pelvic endometriosis; surgical treatment (laparoscopy); serum biomarkers evaluation;
Key exclusion criteria
Age less that 16 years; no evidence of endometriosis at surgery; previous diagnosis of fibromyalgia
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Policlinico of Abano Terme, Padua, Italy
Division name
Obstetrics and Gynecology
Zip code
Address
Piazza Cristoforo Colombo 1 - 35031 Abano Terme (PD) - Italy
TEL
+393498724206
marcoscioscia@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Policlinico of Abano Terme
Division name
Obstetrics and Gynecology
Zip code
Address
Piazza Cristoforo Colombo 1 - 35031 Abano Terme (PD) - Italy
TEL
+393498724206
Homepage URL
marcoscioscia@gmail.com
Sponsor or person
Institute
Policlinico of Abano Terme
Institute
Department
Personal name
Funding Source
Organization
Policlinico of Abano Terme
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Policlinico of Abano Terme, Padua, Italy
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 19 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data have been collected and the analysis is under way.
Management information
Registered date
| 2018 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037224
