Predicting Outcomes of Breast-Conserving Surgery in Breas... | NCT06770647

Studies
Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index

NCT06770647

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jan 13, 2025Actual

Enrollment

96,586Actual

Phase

Not provided

Conditions

Retrospective Study

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Dec 15, 2024Actual

First Submitted Date

Dec 22, 2024

First Submission Date that Met QC Criteria

Jan 7, 2025

First Posted Date

Jan 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2025

Last Update Posted Date

Jan 13, 2025Actual

Name	Class
Harvard Medical School (HMS and HSDM)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background: Breast cancer is the most common malignancy among women worldwide, with breast-conserving surgery (BCS) being a key treatment. The modified 5-item frailty index (mFI-5), a well-validated tool for assessing frailty, has shown predictive utility in other surgical contexts but remains under-explored in BCS.

Methods: Using the American College of Surgeons National Surgical Quality Improvement Program database (2008-2021), the investigators identified adult female breast cancer patients who underwent BCS. Frailty was assessed using the mFI-5, scored from 0 to 5, with higher scores indicating greater frailty. Multivariable logistic regression was employed to evaluate associations between mFI-5 scores and postoperative outcomes.

Main question: Can the mFI-5 predict adverse postoperative outcomes in breast-conserving surgery patients?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96,586Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General data	Hospital length of stay (in days). Operative time (in minutes).	30 days
Any complications	Patient mortality. (Unplanned) readmission. Surgical and/or medical complications.	30 days
Surgical Complications	Infections (superficial, deep, or organ-space). Wound dehiscence. Bleeding requiring transfusion.	30 days
Medical Complications	Pneumonia. Reintubation. Pulmonary embolism. Ventilator dependence >48 hours. Progressive renal insufficiency. Urinary tract infection. Stroke or cerebrovascular accident. Myocardial infarction. Deep vein thrombosis or thrombophlebitis. Sepsis. Septic shock.	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Data from 14 annual datasets (2008-2021).
Female breast cancer patients identified using diagnostic codes:
ICD-9-CM 174: "Malignant neoplasm of female breast."
ICD-9-CM 233.0: "Carcinoma in situ of breast."
ICD-10-CM C50: "Malignant neoplasm of breast."
ICD-10-CM D05: "Carcinoma in situ of breast."
Focused on patients diagnosed with breast cancer.
Further refinement:
Only patients undergoing breast-conserving surgery (BCS).
Identified by CPT code 19301: "Partial mastectomy without axillary lymphadenectomy."

Exclusion Criteria

Missing essential anthropometric data (height and/or weight).
Implausible BMI values (<7 kg/m² or >250 kg/m², assumed data entry errors).
Miscoded or vague ICD or CPT entries.
Concurrent invasive procedures other than BCS.
Procedures performed by specialties other than general or plastic surgery.
Male and non-binary patients or those with gender identity disorders (to focus on biologically female cohort).
Non-elective (emergency) surgical cases.
Patients with ASA physical status scores >4.
Patients receiving anesthesia types other than general anesthesia.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women with breast cancer

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Breast cancer patients with Breast conserving surgery without lymph node removal

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriana C Panayi, MD PhD	Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technische Universität München		Munich	Bavaria	81675	Germany