Breast CancerCTCNCT01716065
Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)
An observational study of Breast Cancer, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll female and male military health care beneficiaries between the ages 18-85 years old presenting with the diagnosis of primary non-metastatic breast cancer, American Joint Committee on Cancer (AJCC) Stages I, II or III, undergoing surgery with curative intent
Who may be able to join
- Male and female subjects should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy
- Written informed consent must be obtained from each subject prior to entering the study
- Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph node dissection
- Able to stay overnight in the hospital post surgery
Who cannot join
- Any subject younger than 18 years or older than 85 years of age
- History of previous breast surgery (aside from biopsy), planned breast conserving operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)
- American Society of Anesthesia (ASA) classification of 4 or greater, or any contraindication to having regional anesthesia
- Any subjects who receives an intraoperative or postoperative blood transfusion during the period of venous blood sampling
- Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study
- Subjects with active infectious process at the site of proposed paravertebral injection
- Subjects with significant allergy to local anesthetics
- Subjects who convert from RA to GA during surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer
The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.
Read the detailed description
There are two different types of anesthesia that the investigators can use for subjects undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine during and after surgery to minimize surgical pain. The other type of anesthesia is called "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.
- Conditions
- Breast Cancer
- Keywords
- Anesthesia, Circulating tumor cells
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating Tumor Cells
blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment
Measured: 5 days
Secondary outcomes (5)
Levels of cytokines
Measured: 5 days
breast cancer antibodies
Measured: 5 days
Dendritic Cells
Measured: 5 days
T and B lymphocytes
Measured: 5 days
Natural Killer Cells (NK cells)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
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.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716065
- Sponsor's protocol ID
- 355841-17
- Acronym
- CTC
- Status last verified
- Apr 2014
- First submitted
- 17 Oct 2012
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01716065
- Acronym / sponsor ID
- CTC / 355841-17
- Conditions
- Breast Cancer
- Keywords
- Anesthesia, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- First posted
- 29 Oct 2012 (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 purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.
Detailed description
There are two different types of anesthesia that the investigators can use for subjects undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine during and after surgery to minimize surgical pain. The other type of anesthesia is called "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll female and male military health care beneficiaries between the ages 18-85 years old presenting with the diagnosis of primary non-metastatic breast cancer, American Joint Committee on Cancer (AJCC) Stages I, II or III, undergoing surgery with curative intent
Key inclusion criteria (4 listed)
- Male and female subjects should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy
- Written informed consent must be obtained from each subject prior to entering the study
- Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph node dissection
- Able to stay overnight in the hospital post surgery
Key exclusion criteria (8 listed)
- Any subject younger than 18 years or older than 85 years of age
- History of previous breast surgery (aside from biopsy), planned breast conserving operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)
- American Society of Anesthesia (ASA) classification of 4 or greater, or any contraindication to having regional anesthesia
- Any subjects who receives an intraoperative or postoperative blood transfusion during the period of venous blood sampling
- Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study
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
Circulating Tumor Cells
Time frame: 5 days
blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment
5 secondary outcomes
Levels of cytokines
Time frame: 5 days
breast cancer antibodies
Time frame: 5 days
Dendritic Cells
Time frame: 5 days
T and B lymphocytes
Time frame: 5 days
Natural Killer Cells (NK cells)
Time frame: 5 days
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 30 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Defense and Veterans Center for Integrative Pain Management 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 4 inclusion and 8 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 30 Apr 2014. 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?
Circulating Tumor Cells (time frame: 5 days). 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 30 Apr 2014.