LymphedemaNCT07855627
Prediction Of Lymphedema In Patients With Inflammatory BreastCancer Using Preoperative Bioimpedance Measurements
An observational study of Lymphedema and Inflammatory Breast Cancer (IBC), run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out whether the BIA test can help identify participants with IBC who are at risk for developing lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Inflammatory Breast Cancer (IBC), Preoperative
- What is being tested?
- Neoadjuvant therapy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: UT MD Anderson Cancer Center
Eligibility Criteria All women≥18 years old with newly diagnosed inflammatory breast cancer without prior breast/axillary surgery who are eligible for standard of care (NST, MRM, and radiation therapy).
Exclusion Criteria Prior breast/axillary surgery. Participants with pacemakers or other implanted electronic medical devices. Participants with implanted metallic material. All vulnerable populations, including children, pregnant women, and cognitively impaired adult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Anthony Lucci, MD, 713-563-1871, ALucci@mdanderson.org
Anthony Lucci, MD
About this study
To find out whether the BIA test can help identify participants with IBC who are at risk for developing lymphedema.
Read the detailed description
Primary Objectives The primary objective is to reliably describe risk factors for development of BCRL in IBC using BIA.
- Being tested
- Neoadjuvant therapy
- Medical subject headings
- Lymphedema, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all patients will start/continue neoadjuvant systemic therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Life Impact Scale (LLIS) questionnaire
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start16 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Lucci, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855627
- Sponsor's protocol ID
- 2026-0423
- Other IDs
- NCI-2026-07135
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Of Lymphedema In Patients With Inflammatory BreastCancer Using Preoperative Bioimpedance Measurements
- ClinicalTrials.gov ID
- NCT07855627
- Acronym / sponsor ID
- 2026-0423
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Oct 2026 (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.
To find out whether the BIA test can help identify participants with IBC who are at risk for developing lymphedema.
Detailed description
Primary Objectives The primary objective is to reliably describe risk factors for development of BCRL in IBC using BIA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant therapyall patients will start/continue neoadjuvant systemic therapy | Drug | – |
Primary outcome
Lymphedema Life Impact Scale (LLIS) questionnaire
Time frame: Through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Anthony Lucci, MD principal investigator
UT MD Anderson Cancer Center
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 Lymphedema and Inflammatory Breast Cancer (IBC), run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Lucci, MD (713-563-1871, ALucci@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema Life Impact Scale (LLIS) questionnaire (time frame: Through study completion; an average of 1 year.). 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 2 Oct 2026.