Clinical trial NCT02091557: CA 125 and VAS Pain Score Changes to Diagnose Endometriosis
Official title: CA 125 and VAS Pain Score Changes Following GnRH-analog Administration as ex Adiuvantibus Criteria to Diagnose Endometriosis as Cause of Chronic Pelvic Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Pain
Endometriosis
Keywords: GnRH-a
endometriosis
chronic pelvic pain
VAS score
diagnostic accuracy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pelvic pain

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic accuracy of composite measure (serum CA 125 levels and VAS pain score changes following one dose of GnRH-a)
timeFrame: One month after LAD administration
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Chair of Obstetrics and Gynecology - University division - UMG
state: CZ
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Fulvio Zullo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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