CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

NCT ID: NCT02091557

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-01-31

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).

Conditions

Pelvic Pain; Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GnRH-analogue

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

GnRH-analogue

Intervention Type: DRUG

Interventions

GnRH-analogue

Intervention Type: DRUG

Other Intervention Names

LAD

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Fulvio Zullo

Full Professor Obstetric Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fulvio Zullo

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University of Catanzaro

Locations

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, Italy

Countries

Italy

References

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

Reference Type: BACKGROUND

Other Identifiers

CA125_VAS_changes

Identifier Type: -

Identifier Source: org_study_id