NCT03370250

Brief Summary

Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been reported to be associated with good prognosis. However, for the patients with large mass or worse mass position, free greater omentum transplantation may provide a new option for breast reconstruction.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1 month

First QC Date

December 6, 2017

Last Update Submit

December 6, 2017

Conditions

Breast Reconstruction

Keywords

immediate breast reconstructionfree greater omentumbreast-conserving surgeryluminal breast cancer

Outcome Measures

Primary Outcomes (1)

  • severe related complication

    Serious adverse effect occur within 1 years after implantation

    1 year after surgery

Secondary Outcomes (3)

  • cosmetic outcome

    6 months after surgery

  • greater omentum survival

    2 and 5 years after surgery

  • Patient satisfaction

    6months, 1 and 2 years after surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The research team selected the patients diagnosed with breast cancer and classified as luminal subtype who received one-sided therapeutic mastectomy and breast reconstruction with free omentum flap between January 23, 2015 and December 6, 2017

You may qualify if:

  • \- Patient aged 18 -60 years Patient diagnosed with luminal breast cancer No neoadjuvant chemotherapy previously No distant metastasis Suitable for breast conserving surgery Willing and able to give written informed consent to participate in the study including all follow-up examinations

You may not qualify if:

  • \- Participate in another clinicaltrial Bilateral lesions Pregnancy or lactation Greater omentum unable to extract or insufficient omentum Other surgical contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Mei ling Huang, MD

CONTACT

029-84775271huangmeiling@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

November 1, 2017

Primary Completion

December 3, 2017

Study Completion

December 31, 2023

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

CN(1)