Clinical trial NCT06770647: Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
Official title: Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retrospective Study
Keywords: mFI-5
Modified 5-Item Frailty Index
Breast conserving surgery
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2025-01-13
Enrollment: 96586
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients with Breast conserving surgery without lymph node removal

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?


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.

Primary outcomes:
measure: General data
timeFrame: 30 days
measure: Any complications
timeFrame: 30 days
measure: Surgical Complications
timeFrame: 30 days
measure: Medical Complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München
state: Bavaria
Study officials:
affiliation: Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
name: Adriana C Panayi, MD PhD
role: STUDY_CHAIR
References: