An interventional study of modified radical mastectomy in Systemic Inflammatory Response Syndrome, sponsored by Kocaeli University. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Kocaeli University · Not applicable, Interventional, and Health services research
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.
89 female breast cancer patient who underwent modified radical mastectomy included into study. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. IL-1β and IL-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. Those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles
195 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's enrollment of 89 is above the median of 76 across 98 interventional studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
postmenopausal female breast cancer patients who underwent modified radical mastectomy
Procedure: modified radical mastectomy
premenopausal female breast cancer patients who underwent modified radical mastectomy
Procedure: modified radical mastectomy
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.
IL-1 and IL-6 levels
evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
Time frame: 5 month
No study locations are listed for this record.
Started Jun 2008 (actual). Primary completion is estimated for Nov 2018, 125 months after the start.
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Systemic Inflammatory Response Syndrome →