Retrospective StudyNCT06770647
Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
An observational study of Retrospective Study, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Retrospective Study
- How many people
- 96,586 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Breast cancer patients with Breast conserving surgery without lymph node removal
Who may be able to join
- 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."
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- 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."
Who cannot join
- 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).
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- Non-elective (emergency) surgical cases.
- Patients with ASA physical status scores >4.
- Patients receiving anesthesia types other than general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
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?
- Conditions
- Retrospective Study
- Keywords
- mFI-5, Modified 5-Item Frailty Index, Breast conserving surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
General data
- Hospital length of stay (in days).
- Operative time (in minutes).
Measured: 30 days
Any complications
- Patient mortality.
- (Unplanned) readmission.
- Surgical and/or medical complications.
Measured: 30 days
Surgical Complications
- Infections (superficial, deep, or organ-space).
- Wound dehiscence.
- Bleeding requiring transfusion.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Aug 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrospective StudyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Adriana C Panayi, MD PhD, Study chair, Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770647
- Sponsor's protocol ID
- 2013P001244
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
- ClinicalTrials.gov ID
- NCT06770647
- Acronym / sponsor ID
- 2013P001244
- Conditions
- Retrospective Study
- Keywords
- mFI-5, Modified 5-Item Frailty Index, Breast conserving surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96,586 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breast cancer patients with Breast conserving surgery without lymph node removal
Key inclusion criteria (10 listed)
- 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."
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General data
Time frame: 30 days
* Hospital length of stay (in days). * Operative time (in minutes).
Any complications
Time frame: 30 days
* Patient mortality. * (Unplanned) readmission. * Surgical and/or medical complications.
Surgical Complications
Time frame: 30 days
* Infections (superficial, deep, or organ-space). * Wound dehiscence. * Bleeding requiring transfusion.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana C Panayi, MD PhD study chair
Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retrospective Study, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General data (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.