- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011815
Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
September 22, 2019 updated by: Seoul National University Hospital
A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
Study Overview
Status
Completed
Conditions
Detailed Description
The biological markers that are assumed to bridge this association are measured and analyzed.
Study Type
Observational
Enrollment (Anticipated)
236
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jongno-gu
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Seoul, Jongno-gu, Korea, Republic of, 140-013
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
University (Tertiary) hospital, oncology clinic
Description
Inclusion Criteria:
- Age: 18-70
- Breast cancer patients who are getting chemotherapy for the first time in life
- Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy.
- Patient have signed on the informed consent, and well understood the objective and procedure of this study
Exclusion Criteria:
- Patients already have received chemotherapy
- Patient had another cancer (except thyroid cancer) within 5 years
- Patient with severe medical condition
- Patient had taken psychiatric medication more than 1 month in life
- Patient worked the night shift for more than 1 month in 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast cancer
Diagnosed breast cancer patients who are getting chemotherapy for the first time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 3 years (and more) after recruitment
|
The data progression-free survival will be done by reviewing patients' medical record.
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3 years (and more) after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circadian disruption
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
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Baseline, after 1 month, after 6 month, after 12 month
|
Objective sleep cycle measures
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
The assessment will be performed by using actigraph and sleep diary.
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Baseline, after 1 month, after 6 month, after 12 month
|
Physiological measures
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
|
Baseline, after 1 month, after 6 month, after 12 month
|
Sleep quality measures
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.
|
Baseline, after 1 month, after 6 month, after 12 month
|
Quality of Life measure
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
The measurement will be performed using M.D. Anderson Symptom Inventory.
|
Baseline, after 1 month, after 6 month, after 12 month
|
Cancer related Fatigue
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
Fatigue severity scale will be used during the assessment.
|
Baseline, after 1 month, after 6 month, after 12 month
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Distress related measure
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
Hospital Anxiety and Depression Scale will be used during the assessment.
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Baseline, after 1 month, after 6 month, after 12 month
|
Posttraumatic Stress-related symptom measure
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.
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Baseline, after 1 month, after 6 month, after 12 month
|
Menopausal symptom measure
Time Frame: Baseline, after 1 month, after 6 month, after 12 month
|
Menopause Rating Scale will be used during the assessment.
|
Baseline, after 1 month, after 6 month, after 12 month
|
Personality measure
Time Frame: Baseline
|
Temperament and Character Inventory will be used to examine the personality factor in each participant.
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Baseline
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Genetic polymorphism
Time Frame: Baseline
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Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
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Baseline
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Epigenetic Change
Time Frame: Baseline
|
The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.
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Baseline
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Cortisol level
Time Frame: Baseline
|
Salivary cortisol level will be measured multiple times at baseline.
|
Baseline
|
Melatonin
Time Frame: Baseline
|
Salivary or Urine melatonin level will be measured.
|
Baseline
|
Inflammatory markers
Time Frame: Baseline
|
The various inflammation markers will be measured from blood sample.
|
Baseline
|
Overall survival
Time Frame: 3 years (and more) after recruitment
|
The data progression-free survival will be done by reviewing patients' medical record.
|
3 years (and more) after recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 10, 2013
Primary Completion (ACTUAL)
February 15, 2019
Study Completion (ACTUAL)
June 15, 2019
Study Registration Dates
First Submitted
December 10, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (ESTIMATE)
December 13, 2013
Study Record Updates
Last Update Posted (ACTUAL)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 22, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BreastCA_circa_mech
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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