New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

NCT02997787 | Completed

• 1 other identifier: 2016/525
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Both pelvic masses and preoperative diagnosis of them have still continued as an important investigation subject. It is important to discriminate the diagnoses of leiomyoma and adenomyosis before operation especially among infertile patients. Neoplasms can alter systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete blood counter test (CBC). A high NLR has been shown in systemic inflammation, some gynecologic and gastrointestinal cancers and some cardiovascular diseases. The investigators aim to investigate using new inflammation markers, NLR and PLR, whether they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there have been no previous reports about the association among NLR, PLR, adenomyosis and leiomyoma.

Conditions

Adenomyosis; Leiomyoma; Inflammation

Keywords

adenomyosis; leiomyoma; neutrophil to lymphocyte ratio; platelet to lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

• Measured serum inflammatory markers among groups by complete blood count

  Those markers are neutrophil, lymphocyte and platelet count.

  3 months

Study Arms (3)

adenomyosis

First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy

leiomyoma

Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy

control

Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

There were three groups in our study. First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy. Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy.

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

MeSH Terms

Conditions

Adenomyosis; Leiomyoma; Inflammation

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yusuf Madendag

  Kayseri Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-12