UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between serum biomarkers, location of endometriosis lesion, and clinical presentation
Title of the study (Brief title)	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	Marco Scioscia
Organization	Policlinico of Abano Terme, Padua, Italy
Division name	Obstetrics and Gynecology
Address	Piazza Cristoforo Colombo 1 - 35031 Abano Terme (PD) - Italy
TEL	+393498724206
Email	marcoscioscia@gmail.com

Public contact
Name of contact person	Marco Scioscia
Organization	Policlinico of Abano Terme
Division name	Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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