Breast CancerNCT06981689
Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders
An observational study of Breast Cancer, run by Samsung Medical Center.
Trial summary
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 24,930 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study included newly diagnosed female breast cancer patients who underwent total mastectomy followed by breast reconstruction classified into two types using ICD-10 procedure codes: autologous tissue reconstructions were coded from N7140 to N7147 and implant-based reconstructions were coded from N7148 to N7151 Exclusions applied to males, individuals who underwent reconstruction prior to mastectomy, and those diagnosed with psychiatric disorders within one year prior to surgery
Who may be able to join
- The study included newly diagnosed female breast cancer patients who underwent total mastectomy
Who cannot join
- individuals who underwent reconstruction prior to mastectomy
- those diagnosed with psychiatric disorders within one year prior to surgery
About this study
Official title: Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders: A Target Trial Emulation
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction
Read the detailed description
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction
- Conditions
- Breast Cancer
- Keywords
- autologous reconstruction, implant-based reconstruction, psychiatric disorders
- Medical subject headings
- Breast Neoplasms, Mental Disorders
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 |
|---|---|---|
| autologous reconstruction | autologous reconstruction following mastectomy | |
| implant-based reconstruction | implant-based reconstruction following mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric disorders
The primary endpoint was clinically diagnosed psychiatric disorder, defined as the first occurrence of a diagnosis made by a physician for any of the following major psychiatric conditions: anxiety disorders (F40, F41), bipolar disorder (F30, F31, F34.0), depressive disorders (F32, F33), sleep disorders (G47.0, F51.0), obsessive-compulsive disorder (F42), posttraumatic stress disorder (F43.1), and substance use disorders (F10-F19).
Measured: 1 year, 5 year and 9 year since surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Retrospective
- Enrolment
- 24,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danbee Kang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981689
- Sponsor's protocol ID
- AR vs. IBR
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders: A Target Trial Emulation
- ClinicalTrials.gov ID
- NCT06981689
- Acronym / sponsor ID
- AR vs. IBR
- Conditions
- Breast Cancer
- Keywords
- autologous reconstruction, implant-based reconstruction, psychiatric disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,930 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 May 2025 (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.
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction
Detailed description
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous reconstruction | – | –autologous reconstruction following mastectomy |
| implant-based reconstruction | – | –implant-based reconstruction following mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included newly diagnosed female breast cancer patients who underwent total mastectomy followed by breast reconstruction classified into two types using ICD-10 procedure codes: autologous tissue reconstructions were coded from N7140 to N7147 and implant-based reconstructions were coded from N7148 to N7151 Exclusions applied to males, individuals who underwent reconstruction prior to mastectomy, and those diagnosed with psychiatric disorders within one year prior to surgery
Key inclusion criteria (1 listed)
- The study included newly diagnosed female breast cancer patients who underwent total mastectomy
Key exclusion criteria (2 listed)
- individuals who underwent reconstruction prior to mastectomy
- those diagnosed with psychiatric disorders within one year prior to surgery
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
Psychiatric disorders
Time frame: 1 year, 5 year and 9 year since surgery
The primary endpoint was clinically diagnosed psychiatric disorder, defined as the first occurrence of a diagnosis made by a physician for any of the following major psychiatric conditions: anxiety disorders (F40, F41), bipolar disorder (F30, F31, F34.0), depressive disorders (F32, F33), sleep disorders (G47.0, F51.0), obsessive-compulsive disorder (F42), posttraumatic stress disorder (F43.1), and substance use disorders (F10-F19).
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Samsung Medical Center.
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 1 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: finished, as of the sponsor's last update on 21 May 2025. 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?
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?
Psychiatric disorders (time frame: 1 year, 5 year and 9 year since surgery). 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 21 May 2025.