NCT05213962

Enrolling By Invitation

Local and Regional Radiotherapy for Nipple Sparing Mastectom...

National Cancer Center, Korea Source

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Other study identifiers

Sponsor study identifier

NCC2021-0335

Study Type

observational

Estimated enrollment

128

Locations

1 country

Sites

1

Timeline

Study Start

November 15, 2021

Actual (reported)

Primary Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node) with a high risk of local recurrence in nipple-sparing mastectomy with reconstruction, we're going to analysis the effects of radiation therapy and cosmetic effects. By evaluating survival rate, recurrence pattern(local lymph node and metastasis to the whole body), side effects, cosmetic effects, from the patients who have gone through Nipple Sparing Mastectomy with reconstruction.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: enrolling by invitation
Estimated enrollment: 128 participants
Study completion date: December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 15, 2021
Actual (reported)
First Submitted
December 21, 2021
Actual (reported)
First Posted
January 28, 2022
Actual (reported)
Primary Completion
December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: January 28, 2022
Status Verified: January 2022
Last Update Submitted: January 17, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

freedom from local and regioanl recurrence rate : FFLRR rate
evaluate the freedom from local and regioanl recurrence rate in nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node)
up to 5 years

Secondary Outcomes (2)

relapse-free or overall survivor : RFS and OS
up to 5 years
toxicity and contraction of the implant, quality of life
up to 5 years

Eligibility Criteria

Age20 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Breast cancer patients receiving nipple sparing mastectomy with breast reconstruction

You may qualify if:

patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma

Sponsors & Collaborators

National Cancer Center, Korea
Governmentlead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Tae hyun Kim, Ph.D
National Cancer Center, Korea
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 28, 2022

Study Start

November 15, 2021

Actual (reported)

Primary Completion

December 31, 2028

Estimated

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Phase 2Completed

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Recruiting

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Not ApplicableUnknown

NCT06299930

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Completed

NCT03975179

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Not ApplicableUnknown

patient who undergone nipple sparing mastectomy with construction

patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2)

patient who have not distant metastasis

age \>19 years old

patinet who have an ECOG of 0-2

patient who have not comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)

patient who have not prior radiotherapy history in treatment site

patient who have not pregnancy or lacting

patient who have consent in writing to participate in research

You may not qualify if:

patient who undergone construction after nipple sparing mastectomy
patient who have ≥T3, ≥N2 in breast cancer
patient who have diastant metastasis
patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
patient who have treatment history in treatment site
patinet who have an ECOG 3-4
age \< 20years old
patient who have pregnancy or lacting
patient who have not consent in writing to participate in research

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

January 28, 2022

Record last verified: 2022-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05213962
Data provider: ClinicalTrials.gov
Source updated: 2022-01-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:12 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations