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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The biological markers that are assumed to bridge this association are measured and analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 140-013
        • Seoul National University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Breast cancer
Diagnosed breast cancer patients who are getting chemotherapy for the first time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
3 years (and more) after recruitment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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
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.
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.
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.
Baseline
Genetic polymorphism
Time Frame: Baseline
Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined.
Baseline
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.
Baseline
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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