CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

NCT02091557 | Completed DMC

• 1 other identifier: CA125_VAS_changes
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Pain; Endometriosis

Keywords

GnRH-a; endometriosis; chronic pelvic pain; VAS score; diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GnRH-analogue

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

Drug: GnRH-analogue

Interventions

GnRH-analogue DRUG

Also known as: LAD

GnRH-analogue

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pelvic pain

You may qualify if:

• chronic pelvic pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Endometriosis

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Fulvio Zullo

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetric Gynecology

Study Record Dates

• First Submitted: March 15, 2014
• First Posted: March 19, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

IT (1)