NCT04571307

Brief Summary

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 31, 2020

Last Update Submit

August 31, 2021

Conditions

Breast DiseasePhyllodes Breast Tumor

Outcome Measures

Primary Outcomes (4)

  • recurrence of the lesion

    assessed on ultrasound

    2 years from procedure

  • breast cosmetic outcome

    patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score

    at 1 year post procedure

  • pain score

    using pain score scale of 0-10, a higher score indicates a worse outcome

    immediate post procedure

  • pain score

    using pain score scale of 0-10, a higher score indicates a worse outcome

    at 2 weeks post procedure

Interventions

cryotherapyPROCEDURE

comparison between cryotherapy and surgery

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lesion seen on ultrasound
  • core biopsy revealed FEL of B3
  • lesion \</+3.5cm
  • keen for cryotherapy instead of surgery
  • has other breast lesions for followup

You may not qualify if:

  • cancer patients
  • patients with bleeding diathesis
  • lesions causing visible breast deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast DiseasesPhyllodes Tumor

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Geok hoon lim

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geok Hoon Lim

CONTACT

96392353lim.gh@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

October 1, 2020

Study Start

September 15, 2021

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

SG(1)