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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032645
Receipt No. 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

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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 Obsterics 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
Email 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
Email marcoscioscia@gmail.com

Sponsor
Institute Policlinico of Abano Terme
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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