Breast CancerNCT01433302
Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
An observational study of Breast Cancer and Genitourinary Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Genitourinary Cancer, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Punch Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- 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: UT MD Anderson Cancer Center patients, 18 years of age or older, undergoing lymphatico-venular bypass for stage II or greater lymphedema.
Who may be able to join
- Patients undergoing lymphatico-venular bypass for lymphedema.
- History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
- A minimum of three (3) months post-op from any surgical interventions.
- A minimum of six (6) months from the last dose of chemotherapy.
- Patients with unilateral lymphedema.
Who cannot join
- Active systemic infection or allergic reaction.
- Active parasitic infection.
- History of primary (congenital) lymphedema.
- Metastatic cancer.
- History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
- History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
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- Current treatment with steroids.
- Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
- Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
- History of bone marrow transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.
Read the detailed description
If you choose to take part in this study, you will have 1 small piece of tissue (about the size of a pencil eraser) collected from the arm with the lymphedema and another small piece of tissue will be collected from the unaffected arm. A total of 4 samples will be collected by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.
Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood sample again 6 months after the surgery. If possible, the blood samples will be collected during already scheduled blood draws to avoid additional needle sticks.
The tissue and blood samples will be used for testing to evaluate the level of the tissue inflammation and to check for any build-up of excess tissue.
Length of Study:
After both tissue and blood samples have been collected, your participation in this study will be over.
This is an investigational study.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer, Genitourinary Cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma
- Being tested
- Punch Biopsy
- Keywords
- Breast cancer, Genitourinary cancer, Gynecological cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma, Inflammatory Response, Inflammatory proteins, Tissue Fibrosis, Lymphatico-venous Bypass Surgery, Punch biopsy, Lab collections, Th2 immune phenotype, Lymphedema
- Medical subject headings
- Breast Neoplasms, Urogenital Neoplasms, Melanoma, Sarcoma, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch BiopsyProcedure or surgery
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
| Study group | Role | What they receive |
|---|---|---|
| Punch Biopsy | Not described Receives: Procedure: Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th2 Cytokine Levels
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- David W. Chang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433302
- Sponsor's protocol ID
- 2011-0455
- Other IDs
- BC103691
- Status last verified
- May 2015
- First submitted
- 8 Sep 2011
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
- ClinicalTrials.gov ID
- NCT01433302
- Acronym / sponsor ID
- 2011-0455
- Conditions
- Breast Cancer, Genitourinary Cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma
- Keywords
- Breast cancer, Genitourinary cancer, Gynecological cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma, Inflammatory Response, Inflammatory proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Sep 2011 (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.
The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.
Detailed description
If you choose to take part in this study, you will have 1 small piece of tissue (about the size of a pencil eraser) collected from the arm with the lymphedema and another small piece of tissue will be collected from the unaffected arm. A total of 4 samples will be collected by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.
Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood sample again 6 months after the surgery. If possible, the blood samples will be collected during already scheduled blood draws to avoid additional needle sticks.
The tissue and blood samples will be used for testing to evaluate the level of the tissue inflammation and to check for any build-up of excess tissue.
Length of Study:
After both tissue and blood samples have been collected, your participation in this study will be over.
This is an investigational study.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Punch Biopsy | – | Procedure: Punch Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center patients, 18 years of age or older, undergoing lymphatico-venular bypass for stage II or greater lymphedema.
Key inclusion criteria (5 listed)
- Patients undergoing lymphatico-venular bypass for lymphedema.
- History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
- A minimum of three (3) months post-op from any surgical interventions.
- A minimum of six (6) months from the last dose of chemotherapy.
- Patients with unilateral lymphedema.
Key exclusion criteria (10 listed)
- Active systemic infection or allergic reaction.
- Active parasitic infection.
- History of primary (congenital) lymphedema.
- Metastatic cancer.
- History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
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 |
|---|---|---|
| Punch Biopsy5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location. | Procedure or surgery | Punch Biopsy |
Primary outcome
Th2 Cytokine Levels
Time frame: 6 months
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
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 6 May 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink 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. This study is not recruiting at the moment.
David W. Chang, MD principal investigator
M.D. 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 Breast Cancer and Genitourinary Cancer, 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?
The sponsor lists 5 inclusion and 10 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 6 May 2015. 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?
Th2 Cytokine Levels (time frame: 6 months). 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 6 May 2015.