NCT06770647Completed
Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
Source: ClinicalTrials.gov · Last updated 13 Jan 2025
Brief summary (registry, in English)
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?
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 96586 (actual)
- First submitted
- 22 Dec 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Technical University of Munich
- Diseases
- Childhood cancers
- NCT number
- NCT06770647
What you commit to
- Study type: Observational
- Participants enrolled: 96586
- From 1 Jul 2024 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent invasive procedures other than BCS.
- Procedures performed by specialties other than general or plastic surgery.
- Non-elective (emergency) surgical cases.
- Patients receiving anesthesia types other than general anesthesia.
Other illness
- Male and non-binary patients or those with gender identity disorders (to focus on biologically female cohort).
Other
- 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.
- Patients with ASA physical status scores \>4.
Who the study is looking for
- 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."
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Technische Universität München Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.