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OpenTrials
Completed

NCT Number: NCT02091557

CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

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).

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GnRH-analogue

Drug

Other names: LAD

Primary outcomes

  1. Diagnostic accuracy of composite measure (serum CA 125 levels and VAS pain score changes following one dose of GnRH-a)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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