Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy

NCT ID: NCT03523078

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-02-01

Brief Summary

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This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Breast reconstructive surgery

All sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed invasive breast carcinoma
* Women who underwent mastectomy and breast reconstruction
* Good performance status (ECOG 0-1)

Exclusion Criteria

* Recurrent breast cancer
* History of ipsilateral breast irradiation
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Korea, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Bae Kim, MD, PhD

Role: CONTACT

82-2228-8095

Facility Contacts

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YongBae Kim, MD

Role: primary

82-10-6256-2592

References

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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.

Reference Type DERIVED
PMID: 33517043 (View on PubMed)

Chang 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.

Reference Type DERIVED
PMID: 31024845 (View on PubMed)

Other Identifiers

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4-2017-1108

Identifier Type: -

Identifier Source: org_study_id

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