NCT03283345

Brief Summary

It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

10.4 years

First QC Date

August 20, 2017

Last Update Submit

September 15, 2017

Conditions

Systemic Inflammatory Response Syndrome

Keywords

breast cancermenstrual cyclebreast surgerysystemic responses to trauma

Outcome Measures

Primary Outcomes (1)

  • IL-1 and IL-6 levels

    evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.

    5 month

Study Arms (2)

postmenopausal women

ACTIVE COMPARATOR

postmenopausal female breast cancer patients who underwent modified radical mastectomy

Procedure: modified radical mastectomy

premenopausal women

ACTIVE COMPARATOR

premenopausal female breast cancer patients who underwent modified radical mastectomy

Procedure: modified radical mastectomy

Interventions

modified radical mastectomyPROCEDURE

systemic responses to trauma are compared with evaluating inflammatory cytokine levels between premenopausal and postmenopausal patient groups with different estrogen levels who underwent modified radical mastectomy.

postmenopausal womenpremenopausal women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • female patients
  • who underwent modified radical mastectomy for breast cancer
  • who signed informed consent forms

You may not qualify if:

  • For premenopausal patients taking oral contraceptives
  • for postmenopausal patients taking hormone replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeBreast Neoplasms

Interventions

Mastectomy, Modified Radical

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy, RadicalMastectomySurgical Procedures, Operative

Study Officials

  • Cantürk

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 20, 2017

First Posted

September 14, 2017

Study Start

June 1, 2008

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

September 18, 2017

Record last verified: 2017-09