Systemic Inflammatory Response SyndromeNCT03283345
Effect of Menstrual Cycle on Traumatic Systemic Response
A study testing modified radical mastectomy in people with Systemic Inflammatory Response Syndrome, run by Kocaeli University.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- What is being tested?
- modified radical mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- female patients
- who underwent modified radical mastectomy for breast cancer
- who signed informed consent forms
Who cannot join
- For premenopausal patients taking oral contraceptives
- for postmenopausal patients taking hormone replacement therapy.
About this study
Official title: ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
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.
Read the detailed description
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
- Conditions
- Systemic Inflammatory Response Syndrome
- Being tested
- modified radical mastectomy
- Keywords
- breast cancer, menstrual cycle, breast surgery, systemic responses to trauma
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified radical mastectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal women | Active comparator | postmenopausal female breast cancer patients who underwent modified radical mastectomy Receives: Procedure: modified radical mastectomy |
| premenopausal women | Active comparator | premenopausal female breast cancer patients who underwent modified radical mastectomy Receives: Procedure: modified radical mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1 and IL-6 levels
evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startJun 2008
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayal Uzelli Şimşek, Kocaeli University
- Investigators
- Cantürk, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283345
- Sponsor's protocol ID
- 2008/69
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
- ClinicalTrials.gov ID
- NCT03283345
- Acronym / sponsor ID
- 2008/69
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- breast cancer, menstrual cycle, breast surgery, systemic responses to trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postmenopausal women | Active comparator | Procedure: modified radical mastectomypostmenopausal female breast cancer patients who underwent modified radical mastectomy |
| premenopausal women | Active comparator | Procedure: modified radical mastectomypremenopausal female breast cancer patients who underwent modified radical mastectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- female patients
- who underwent modified radical mastectomy for breast cancer
- who signed informed consent forms
Key exclusion criteria (2 listed)
- For premenopausal patients taking oral contraceptives
- for postmenopausal patients taking hormone replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified radical mastectomysystemic 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. | Procedure or surgery | postmenopausal women, premenopausal women |
Primary outcome
IL-1 and IL-6 levels
Time frame: 5 month
evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cantürk study director
Kocaeli University
Questions about this trial
What is this clinical trial studying?
A study testing modified radical mastectomy in people with Systemic Inflammatory Response Syndrome, run by Kocaeli University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1 and IL-6 levels (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.