Breast CancerGPSNCT01156454
Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling
An observational study of Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- X-ray
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males or females of all races and ethnicities, must be equal to or greater than 18 years of age, scheduled for breast cancer surgery that includes sentinel node biopsy and/or axillary dissection
Who may be able to join
- Males or females of all races and ethnicities
- ≥ 18 years of age
- Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection
Who cannot join
- Any person whose final pathology could be compromised in any way by the X-ray procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling (GPS)
X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.
- Conditions
- Breast Cancer
- Being tested
- X-ray
- Keywords
- sentinel lymph node dissection, radiology, X-ray identification of nodes in a surgical specimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rayProcedure or surgery
surgical specimen taken to radiology and contents x-rayed
| Study group | Role | What they receive |
|---|---|---|
| Surgery followed by x-ray assessment | After nodes are removed they are taken to radiology to be x-rayed Receives: Procedure: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of lymph nodes
To determine if plain x-ray films obtained from the sentinel node/axillary dissection specimen can facilitate the identification of the lymph nodes and increase the average number of lymph nodes recovered by the pathologist.
Measured: Within the first 30 minutes after specimen is removed from the body
Identification of affected area in node
To determine whether plain x-ray films obtained from the sentinel node/axillary dissection specimen can help direct the pathologist to the correct part of the node (the portion containing disease) to sample.
Measured: Within the first 30 minutes after specimen is removed from the body
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Tenenbaum Family Foundation
- Responsible party
- Sponsor
- Investigators
- V. Suzanne Klimberg, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156454
- Sponsor's protocol ID
- 111743
- Acronym
- GPS
- Status last verified
- Dec 2016
- First submitted
- 24 Jun 2010
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson CB, Korourian S, Badgwell BD, Fincher RL, Dell CM, Don Bice C, Boneti C, Westbrook KC, Klimberg VS. Sensitivity of axillary specimen x-ray to predict nodal count and positivity. Ann Surg Oncol. 2011 Oct;18(11):3181-6. doi: 10.1245/s10434-011-1959-x. Epub 2011 Aug 23.
PubMed 21861231
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling (GPS)
- ClinicalTrials.gov ID
- NCT01156454
- Acronym / sponsor ID
- GPS / 111743
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node dissection, radiology, X-ray identification of nodes in a surgical specimen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Tenenbaum Family Foundation
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- 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.
X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery followed by x-ray assessment | – | Procedure: X-rayAfter nodes are removed they are taken to radiology to be x-rayed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males or females of all races and ethnicities, must be equal to or greater than 18 years of age, scheduled for breast cancer surgery that includes sentinel node biopsy and/or axillary dissection
Key inclusion criteria (3 listed)
- Males or females of all races and ethnicities
- ≥ 18 years of age
- Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection
Key exclusion criteria (1 listed)
- Any person whose final pathology could be compromised in any way by the X-ray procedure
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 |
|---|---|---|
| X-raysurgical specimen taken to radiology and contents x-rayed | Procedure or surgery | Surgery followed by x-ray assessment |
Primary outcome
Identification of lymph nodes
Time frame: Within the first 30 minutes after specimen is removed from the body
To determine if plain x-ray films obtained from the sentinel node/axillary dissection specimen can facilitate the identification of the lymph nodes and increase the average number of lymph nodes recovered by the pathologist.
Identification of affected area in node
Time frame: Within the first 30 minutes after specimen is removed from the body
To determine whether plain x-ray films obtained from the sentinel node/axillary dissection specimen can help direct the pathologist to the correct part of the node (the portion containing disease) to sample.
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 23 Dec 2016.
- Results publication: PubMed 21861231Johnson CB, Korourian S, Badgwell BD, Fincher RL, Dell CM, Don Bice C, Boneti C, Westbrook KC, Klimberg VS. Sensitivity of axillary specimen x-ray to predict nodal count and positivity. Ann Surg Oncol. 2011 Oct;18(11):3181-6. doi: 10.1245/s10434-011-1959-x. Epub 2011 Aug 23.
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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.
V. Suzanne Klimberg, MD principal investigator
UAMS
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 Breast Cancer, run by University of Arkansas 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?
The sponsor lists 3 inclusion and 1 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 23 Dec 2016. 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?
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?
Identification of lymph nodes (time frame: Within the first 30 minutes after specimen is removed from the body). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156454, which also lists 1 linked publication.
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 23 Dec 2016.