UMIN-CTR Clinical Trial

Public title

Aesthetic Subunits and Optimal Surgical Margins in the Surgical Management of Facial Basal Cell Carcinoma

Acronym

Aesthetic Subunits and Optimal Surgical Margins in the Surgical Management of Facial Basal Cell Carcinoma

Scientific Title

Evaluation of Aesthetic Subunits and Optimal Surgical Margins in the Surgical Management of Facial Basal Cell Carcinoma

Scientific Title:Acronym

Evaluation of Aesthetic Subunits and Optimal Surgical Margins in the Surgical Management of Facial Basal Cell Carcinoma

Region

Japan

Condition

Facial Basal Cell Carcinoma

Classification by specialty

Dermatology	Plastic surgery	Aesthetic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Basal cell carcinoma is a malignant skin tumor that rarely metastasizes distantly and is generally considered curable with appropriate treatment. Several factors influence the management of BCC, including tumor size, location, tumor borders, degree of pigmentation, and histopathological findings.
BCC frequently occurs in the head and neck region, particularly on the face. Due to both anatomical and aesthetic considerations, it is often difficult in practice to achieve an adequate surgical margin (more than 4 mm) when excising facial lesions. Consequently, numerous studies have compared different margin widths to determine the appropriate surgical margin.
In this study, using existing medical records and pathological specimens, facial BCCs will be classified according to aesthetic subunits. The histopathological findings and postoperative recurrence rates for each subunit will be analyzed in order to evaluate appropriate surgical margins and reconstructive strategies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Resected basal cell carcinomas will be classified according to facial aesthetic subunits and clinical data including tumor size, tumor borders and degree of pigmentation, surgical findings, surgical margin and reconstructive method, and the presence or absence of recurrence will be obtained from electronic medical records. The risk of recurrence (low risk or high risk) will be evaluated according to the NCCN Guidelines (version 2, 2025).
Histopathological findings of the resected BCCs including BCC subtype and the status of horizontal and vertical surgical margins will be obtained from pathological reports preserved in our department. Histological slides stored in the pathology department of our hospital will be used.
Reconstructive procedures will be compared between patients who underwent immediate, single stage reconstruction following tumor excision and those who underwent delayed, two stage reconstruction and differences in recurrence rates between the two groups will be evaluated.
Tumor size and depth of invasion will be measured and evaluated based on histopathological examination.

Key secondary outcomes

The relationship between BCC subtype, horizontal and vertical margin status, and the recurrence rate at one year postoperatively will be analyzed.
Tumor characteristics associated with positive surgical margins will be evaluated, and risk factors for margin positivity will be analyzed statistically.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent surgical excision of facial basal cell carcinoma at our department between January 1, 2013, and December 31, 2022, with at least one year of postoperative follow-up.

Key exclusion criteria

Patients who did not consent to the use of their clinical data for research or academic presentations.

Target sample size

100

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Urushidate

Organization

Hirosaki University Graduate school of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

0368562

Address

5 Zaifu-cho, Hirosaki City, Aomori 036-8562, Japan.

TEL

0172395119

Email

urushi@hirosaki-u.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Urushidate

Organization

Hirosaki University Graduate school of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

0368562

Address

5 Zaifu-cho, Hirosaki City, 036-8562 Aomori, Japan.

TEL

0172395119

Homepage URL

Email

kk505199@gmail.com

Institute

Hirosaki University Graduate school of Medicine

Institute

Department

Personal name

Satoshi Urushidate

Organization

non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Jichi Medical University

Name of secondary funder(s)

Organization

Hirosaki University Graduate school of Medicine

Address

5 Zaifu-cho, Hirosaki City, 036-8562 Aomori, Japan.

Tel

0172395119

Email

kk505199@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

112

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2025

Year

06

Month

23

Day

Date of IRB

2025

Year

06

Month

24

Day

Anticipated trial start date

2025

Year

07

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study uses procedures and pathological examinations performed as part of routine clinical practice and utilizes existing specimens. Therefore, there will be no direct patient involvement or intervention. In addition, no new risks to patients are anticipated as a result of conducting this study. For these reasons, the study will be conducted using an opt-out approach.
The progress of this study will be reported annually in writing by the principal investigator to the Ethics Committee of the Graduate School of Medicine, Hirosaki University.
If the study is discontinued or completed, the principal investigator will submit a written report to the Ethics Committee of the Graduate School of Medicine, Hirosaki University.
If concerns arise regarding the leakage of research-related information, or if information is obtained that may compromise the appropriateness of the study implementation or the reliability of the research results, the matter will be promptly reported in writing to the principal investigator.

Registered date

2026

Year

03

Month

14

Day

Last modified on

2026

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069735