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

January 7, 2025 updated by: Technical University of Munich

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96586

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients with Breast conserving surgery without lymph node removal

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
General data
Time Frame: 30 days
  • Hospital length of stay (in days).
  • Operative time (in minutes).
30 days
Any complications
Time Frame: 30 days
  • Patient mortality.
  • (Unplanned) readmission.
  • Surgical and/or medical complications.
30 days
Surgical Complications
Time Frame: 30 days
  • Infections (superficial, deep, or organ-space).
  • Wound dehiscence.
  • Bleeding requiring transfusion.
30 days
Medical Complications
Time Frame: 30 days
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adriana C Panayi, MD PhD, Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013P001244

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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