CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

Completed

• Conditions: Endometriosis; Pelvic Pain
• Interventions: Drug: GnRH-analogue

• Registration Number: NCT02091557
• Lead Sponsor: University Magna Graecia

Brief Summary

To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of the combination of two simple parameters: modifications of serum CA 125 and VAS pain score following one dose of GnRH-analog (GnRH-a).

Detailed Description

Between January 2010 and January 2014, women scheduled for a diagnostic laparoscopy for CPP at our Department will be enrolled in the current prospective observational study. For these patients, laparoscopy represents the last diagnostic step after medical history negative for gastrointestinal, urological, musculoskeletal and psychoneurological disorders related to pelvic pain, physical examination, ultrasonographic assessment and laboratory testing. From all patients, at enrollment, blood samples for serum CA125 determination will be taken during the early follicular phase (2nd-3rd day of the menstrual cycle) and VAS score for menstrual pain will be assessed. Electrochemiluminescence immunoassay (Immunoassay Elecsys Systems, Roche Diagnostics, Italy) for serum CA125 assay will be used (kit coefficient of variation between-run 0.0% and within-run 2.0%).

During the time passed on surgery waiting list, patients will received leuprolide acetate depot (LAD) at a dose of 3.75 mg IM at the 21st day of the menstrual cycle. One month later LAD administration, serum CA125 levels and VAS score will be assessed again, and then the surgical procedure will be performed in all these patients.

After laparoscopy and definitive histological examination, the population initially enrolled will be sub-grouped according to endometriosis diagnosis in two groups, i.e. group 1 (subjects with endometriosis) and group 2 (subjects without endometriosis).

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-03-15
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-28
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

• chronic pelvic pain

Exclusion Criteria

• age less than 18 and greater than 38
• oligo-amenorrhea
• use of hormone medications (including oral contraceptives pill, progestogens, and so on)
• conditions affecting serum CA125 levels (such as, pregnancy, ovarian endometrioma seen at ultrasonography, pelvic inflammatory diseases, neoplasm, tuberculosis, hepatitis, peritonitis, recent abdominal surgery and pelvic organic disease)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GnRH-analogue	GnRH-analogue	CA125 levels and VAS pain score changes will be assessed after GnRH-a administration in all patients

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of composite measure (serum CA 125 levels and VAS pain score changes following one dose of GnRH-a)	One month after LAD administration	Diagnostic accuracy (specificity, sensitivity, AUC and cut off levels) of the modifications of serum CA 125 levels and VAS pain score following one dose of LAD (composite measure)

Trial Locations

Locations (1)

Chair of Obstetrics and Gynecology - University division - UMG; 🇮🇹 Catanzaro, CZ, Italy