CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

CA 125 and VAS Pain Score Changes Following GnRH-analog Administration as ex Adiuvantibus Criteria to Diagnose Endometriosis as Cause of Chronic Pelvic Pain.

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).

Study Overview

• Status: Completed
• Conditions: Endometriosis; Pelvic Pain
• Intervention / Treatment: Drug: GnRH-analogue

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 Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Italy
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Chair of Obstetrics and Gynecology - University division - UMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pelvic pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GnRH-analogue; CA125 levels and VAS pain score changes will be assessed after GnRH-a administration in all patients	Drug: GnRH-analogue; Other Names: LAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of composite measure (serum CA 125 levels and VAS pain score changes following one dose of GnRH-a)	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)	One month after LAD administration

Collaborators and Investigators

• Sponsor: University Magna Graecia

Publications and helpful links

General Publications

• Venturella R., et al. CA 125 modifications throughout menstrual cycle and following GnRH-analog administration to diagnose endometriosis as cause of chronic pelvic pain.A prospective controlled study. Journal of Endometriosis 2011; 3(3): 151 - 158. DOI: 10.5301/JE.2011.8911

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 15, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 28, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: diagnostic accuracy; endometriosis; VAS score; chronic pelvic pain; GnRH-a
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: CA125_VAS_changes