Breast NeoplasmsNCT02011815
Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2013to 15 Jun 2019
- Phase
- Observational
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: University (Tertiary) hospital, oncology clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 140-013
About this study
Official title: 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.
Read the detailed description
The biological markers that are assumed to bridge this association are measured and analyzed.
- Conditions
- Breast Neoplasms
- Keywords
- Breast neoplasms, Circadian rhythm, sleep, survival, distress, anxiety, depression, quality of life, actigraph, fatigue
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Diagnosed breast cancer patients who are getting chemotherapy for the first time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The data progression-free survival will be done by reviewing patients' medical record.
Measured: 3 years (and more) after recruitment
Secondary outcomes (16)
Circadian disruption
Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Objective sleep cycle measures
The assessment will be performed by using actigraph and sleep diary.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Physiological measures
The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Sleep quality measures
The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Quality of Life measure
The measurement will be performed using M.D. Anderson Symptom Inventory.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Cancer related Fatigue
Fatigue severity scale will be used during the assessment.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Distress related measure
Hospital Anxiety and Depression Scale will be used during the assessment.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Posttraumatic Stress-related symptom measure
Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Menopausal symptom measure
Menopause Rating Scale will be used during the assessment.
Measured: Baseline, after 1 month, after 6 month, after 12 month
Personality measure
Temperament and Character Inventory will be used to examine the personality factor in each participant.
Measured: Baseline
Genetic polymorphism
Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
Measured: Baseline
Epigenetic Change
The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level.
Measured: Baseline
Cortisol level
Salivary cortisol level will be measured multiple times at baseline.
Measured: Baseline
Melatonin
Salivary or Urine melatonin level will be measured.
Measured: Baseline
Inflammatory markers
The various inflammation markers will be measured from blood sample.
Measured: Baseline
Overall survival
The data progression-free survival will be done by reviewing patients' medical record.
Measured: 3 years (and more) after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start10 Nov 2013
- Primary completion15 Feb 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bong-Jin Hahm, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011815
- Sponsor's protocol ID
- BreastCA_circa_mech
- Status last verified
- Apr 2018
- First submitted
- 10 Dec 2013
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression
- ClinicalTrials.gov ID
- NCT02011815
- Acronym / sponsor ID
- BreastCA_circa_mech
- Conditions
- Breast Neoplasms
- Keywords
- Breast neoplasms, Circadian rhythm, sleep, survival, distress, anxiety, depression, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2013 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 13 Dec 2013 (estimated)
- 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.
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
Detailed description
The biological markers that are assumed to bridge this association are measured and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | –Diagnosed breast cancer patients who are getting chemotherapy for the first time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University (Tertiary) hospital, oncology clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: 3 years (and more) after recruitment
The data progression-free survival will be done by reviewing patients' medical record.
16 secondary outcomes
Circadian disruption
Time frame: 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
Physiological measures
Time frame: 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
Quality of Life measure
Time frame: 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
Distress related measure
Time frame: 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
Menopausal symptom measure
Time frame: Baseline, after 1 month, after 6 month, after 12 month
Personality measure
Time frame: Baseline
Genetic polymorphism
Time frame: Baseline
Epigenetic Change
Time frame: Baseline
Cortisol level
Time frame: Baseline
Melatonin
Time frame: Baseline
Inflammatory markers
Time frame: Baseline
Overall survival
Time frame: 3 years (and more) after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- study site webpageLink provided by the sponsor.
- Institutional Review BoardLink provided by the sponsor.
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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.
Bong-Jin Hahm, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (time frame: 3 years (and more) after recruitment). 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 24 Sep 2019.