Breast Cancer FemaleNCT03523078
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
An observational study of Breast Cancer Female, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Breast reconstructive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 1 Feb 2024
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing reconstruction surgery after mastectomy at an academic center
Who may be able to join
- Pathologically confirmed invasive breast carcinoma
- Women who underwent mastectomy and breast reconstruction
- Good performance status (ECOG 0-1)
Who cannot join
- Recurrent breast cancer
- History of ipsilateral breast irradiation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Korea, 120-752
YongBae Kim, MD, 82-10-6256-2592, ybkim3@yuhs.ac
About this study
Official title: Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
- Conditions
- Breast Cancer Female
- Being tested
- Breast reconstructive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstructive surgeryProcedure or surgery
All sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Breast-Q questionnaire score
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Measured: Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
Change from baseline of Breast-Q questionnaire score
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Measured: Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Change from baseline of Breast-Q questionnaire score
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Measured: 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Secondary outcomes (1)
Reconstruction complications
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Measured: within 1 year after last reconstruction procedures (plus 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Feb 2018
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523078
- Sponsor's protocol ID
- 4-2017-1108
- Status last verified
- Sep 2020
- First submitted
- 1 May 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung SY, Chang JS, Shin KH, Kim JH, Park W, Kim H, Kim K, Lee IJ, Yoon WS, Cha J, Lee KC, Kim JH, Choi JH, Ahn SJ, Ha B, Lee SY, Lee DS, Lee J, Shin SO, Lee SW, Choi J, Kim MY, Kim YJ, Im JH, Suh CO, Kim YB. Impact of radiation dose on complications among women with breast cancer who underwent breast reconstruction and post-mastectomy radiotherapy: A multi-institutional validation study. Breast. 2021 Apr;56:7-13. doi: 10.1016/j.breast.2021.01.003. Epub 2021 Jan 20.
PubMed 33517043Chang JS, Song SY, Oh JH, Lew DH, Roh TS, Kim SY, Keum KC, Lee DW, Kim YB. Influence of Radiation Dose to Reconstructed Breast Following Mastectomy on Complication in Breast Cancer Patients Undergoing Two-Stage Prosthetic Breast Reconstruction. Front Oncol. 2019 Apr 9;9:243. doi: 10.3389/fonc.2019.00243. eCollection 2019.
PubMed 31024845
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03523078
- Acronym / sponsor ID
- 4-2017-1108
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 14 May 2018 (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.
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing reconstruction surgery after mastectomy at an academic center
Key inclusion criteria (3 listed)
- Pathologically confirmed invasive breast carcinoma
- Women who underwent mastectomy and breast reconstruction
- Good performance status (ECOG 0-1)
Key exclusion criteria (2 listed)
- Recurrent breast cancer
- History of ipsilateral breast irradiation
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 |
|---|---|---|
| Breast reconstructive surgeryAll sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth. | Procedure or surgery | – |
Primary outcome
Change from baseline of Breast-Q questionnaire score
Time frame: Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Change from baseline of Breast-Q questionnaire score
Time frame: Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Change from baseline of Breast-Q questionnaire score
Time frame: 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
1 secondary outcome
Reconstruction complications
Time frame: within 1 year after last reconstruction procedures (plus 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 33517043Chung SY, Chang JS, Shin KH, Kim JH, Park W, Kim H, Kim K, Lee IJ, Yoon WS, Cha J, Lee KC, Kim JH, Choi JH, Ahn SJ, Ha B, Lee SY, Lee DS, Lee J, Shin SO, Lee SW, Choi J, Kim MY, Kim YJ, Im JH, Suh CO, Kim YB. Impact of radiation dose on complications among women with breast cancer who underwent breast reconstruction and post-mastectomy radiotherapy: A multi-institutional validation study. Breast. 2021 Apr;56:7-13. doi: 10.1016/j.breast.2021.01.003. Epub 2021 Jan 20.
- Derived from this study: PubMed 31024845Chang JS, Song SY, Oh JH, Lew DH, Roh TS, Kim SY, Keum KC, Lee DW, Kim YB. Influence of Radiation Dose to Reconstructed Breast Following Mastectomy on Complication in Breast Cancer Patients Undergoing Two-Stage Prosthetic Breast Reconstruction. Front Oncol. 2019 Apr 9;9:243. doi: 10.3389/fonc.2019.00243. eCollection 2019.
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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.
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 Cancer Female, run by Yonsei University 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 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 29 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Bae Kim, MD, PhD (82-2228-8095, ybkim3@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Breast-Q questionnaire score (time frame: Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523078, which also lists 2 linked publications.
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 29 Sep 2020.