Breast Cancer FemaleGENEXANNCT03779685
GENe EXpression After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery
A study testing General anesthesia and Regional anesthesia in people with Breast Cancer Female, run by Azienda Ospedaliera San Gerardo di Monza.
Trial summary
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause of death from cancer in women. It was estimated that 2 million new cases have occurred in 2018 worldwide 1. Standard anesthetic procedures for the surgery of breast cancer include general and regional anesthesia 2. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- General anesthesia and Regional anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-85 years old
- No undergoing pregnancy
- ASA Score I-IV
- Patients scheduled for breast surgery
- No contraindications (including surgical) to regional (paravertebral) anesthesia
- No previous breast surgery
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- No known hereditary or familial cancer syndromes
- No previous cancer anamnesis, radio o chemiotherapy
- Primary breast cancer with Tumor classification 1-3, Nodes 0-2 as determined
- according to the NCI stage definitions (Primary breast cancer without known extension beyond the breast and axillary nodes)
- Free from pain in preoperative period
- Patients who don't use analgesic drugs before surgery
- Patients without cognitive impairment or mental retardation
Who cannot join
- Women > 18, < 85 years old
- Pregnancy
- ASA Score > IV
- Previous breast surgery
- Contraindications to regional anesthesia
- Known hereditary or familial cancer syndromes
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- Previous cancer anamnesis, radio or chemiotherapy
- Tumor classification > 3, Nodes > 2, M > 0 as determined according to the NCI stage
- definitions
- Pain in preoperative period
- Use of analgesic drugs before surgery
- Cognitive impairment or mental retardation
- Patients who did not gave a written informed consent
- Undergoing therapy with alpha (doxazosin) or beta blockers.
About this study
Official title: GENe EXpression in Tissues From Operating Field After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery. The GENEXAN Randomized Controlled Genomic Trial
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause of death from cancer in women. It was estimated that 2 million new cases have occurred in 2018 worldwide 1.
Standard anesthetic procedures for the surgery of breast cancer include general and regional anesthesia 2. Growing preclinical and clinical data support the hypothesis that anesthetic choice may affect cancer-related outcomes.
Recurrence in breast cancer was reduced to four-fold in a retrospective study with a 2.5 to 4 year follow up 3. Recurrence and metastasis-free survival, with multivariate analysis, was 94% (95% CI 87,100) versus 82% (74, 91) at 24 months, and 94 (87, 100) versus 77 (68, 87) at 36 months in the paravertebral and general anesthesia patients, respectively, (p=0.013). Currently large confirmatory randomized trials evaluating breast cancer recurrence in patients operated with general or regional anesthesia are yet undergoing 4.
Read the detailed description
Background: Exposure to general or regional anesthesia, can modulate differently breast cancer biology through a direct activity on cancer cells or indirectly through modifications in host response (immune system, angiogenesis, nervous system). Alterations occur both systemically and locally on the surgical site and is supposed that can affect cancer-related outcomes after months or years.
It is not known whether the action of this short exposure to anesthetics on the host and cancer biology is driven by epigenetic alterations in gene and protein expression during the immediate to early post-anesthesia period.
An altered gene and protein expression profile may affect the response of the immune system, angiogenesis and the nervous system and induce more or less propitious conditions to tumor progression. Data from studies in animals and humans show that gene expression may change in the brain and heart after only a short exposure to general anesthesia and that changes may persist for several weeks.
Methods: The GENEXAN is a randomized, controlled, monocentric, genomic trial aiming to test the hypothesis that regional (paravertebral) anesthesia, compared to general anesthesia, would elicit a differential gene and protein expression pattern in cancer tissue and normal surgical microenvironment after breast cancer surgery in women.
Discussion: This research will serve to map gene and protein expression profile after surgery with different anesthetics and elucidate which genes specific to biological systems may affect tumor biology in the immediate operative period.
The findings may also address further research depending on the tissue specificity of the up or down-regulated genes.
- Conditions
- Breast Cancer Female
- Being tested
- General anesthesia, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Sevoflurane and morphine
Regional anesthesiaProcedure or surgery
Paravertebral block
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print) Receives: Procedure: General anesthesia |
| Regional anesthesia | Experimental | Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print) Receives: Procedure: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole genome expression by microarray
tumor, biopsy, normal wound tissue
Measured: before tumor excision
Whole genome expression by mircoarray
tumor, wound tissue
Measured: during surgery (just after tumor excision)
Secondary outcomes (6)
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
in blood
Measured: before tumor excision
cancer recurrence
local or distant metastasis
Measured: each 6 months for up to 7 years
survival from cancer
death
Measured: each 6 months for up to 7 years
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
in blood
Measured: at the end of surgery
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
in blood
Measured: at 24 hours
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
in blood
Measured: at 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhirajr Mokini M.D., Azienda Ospedaliera San Gerardo di Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779685
- Sponsor's protocol ID
- GENEXAN
- Acronym
- GENEXAN
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENe EXpression in Tissues From Operating Field After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery. The GENEXAN Randomized Controlled Genomic Trial
- ClinicalTrials.gov ID
- NCT03779685
- Acronym / sponsor ID
- GENEXAN / GENEXAN
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Dec 2018 (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.
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause of death from cancer in women. It was estimated that 2 million new cases have occurred in 2018 worldwide 1.
Standard anesthetic procedures for the surgery of breast cancer include general and regional anesthesia 2. Growing preclinical and clinical data support the hypothesis that anesthetic choice may affect cancer-related outcomes.
Recurrence in breast cancer was reduced to four-fold in a retrospective study with a 2.5 to 4 year follow up 3. Recurrence and metastasis-free survival, with multivariate analysis, was 94% (95% CI 87,100) versus 82% (74, 91) at 24 months, and 94 (87, 100) versus 77 (68, 87) at 36 months in the paravertebral and general anesthesia patients, respectively, (p=0.013). Currently large confirmatory randomized trials evaluating breast cancer recurrence in patients operated with general or regional anesthesia are yet undergoing 4.
Detailed description
Background: Exposure to general or regional anesthesia, can modulate differently breast cancer biology through a direct activity on cancer cells or indirectly through modifications in host response (immune system, angiogenesis, nervous system). Alterations occur both systemically and locally on the surgical site and is supposed that can affect cancer-related outcomes after months or years.
It is not known whether the action of this short exposure to anesthetics on the host and cancer biology is driven by epigenetic alterations in gene and protein expression during the immediate to early post-anesthesia period.
An altered gene and protein expression profile may affect the response of the immune system, angiogenesis and the nervous system and induce more or less propitious conditions to tumor progression. Data from studies in animals and humans show that gene expression may change in the brain and heart after only a short exposure to general anesthesia and that changes may persist for several weeks.
Methods: The GENEXAN is a randomized, controlled, monocentric, genomic trial aiming to test the hypothesis that regional (paravertebral) anesthesia, compared to general anesthesia, would elicit a differential gene and protein expression pattern in cancer tissue and normal surgical microenvironment after breast cancer surgery in women.
Discussion: This research will serve to map gene and protein expression profile after surgery with different anesthetics and elucidate which genes specific to biological systems may affect tumor biology in the immediate operative period.
The findings may also address further research depending on the tissue specificity of the up or down-regulated genes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Procedure: General anesthesiaBreast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print) |
| Regional anesthesia | Experimental | Procedure: Regional anesthesiaBreast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Women 18-85 years old
- No undergoing pregnancy
- ASA Score I-IV
- Patients scheduled for breast surgery
- No contraindications (including surgical) to regional (paravertebral) anesthesia
Key exclusion criteria (14 listed)
- Women > 18, < 85 years old
- Pregnancy
- ASA Score > IV
- Previous breast surgery
- Contraindications to regional anesthesia
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 |
|---|---|---|
| General anesthesiaSevoflurane and morphine | Procedure or surgery | General anesthesia |
| Regional anesthesiaParavertebral block | Procedure or surgery | Regional anesthesia |
Primary outcome
Whole genome expression by microarray
Time frame: before tumor excision
tumor, biopsy, normal wound tissue
Whole genome expression by mircoarray
Time frame: during surgery (just after tumor excision)
tumor, wound tissue
6 secondary outcomes
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
Time frame: before tumor excision
cancer recurrence
Time frame: each 6 months for up to 7 years
survival from cancer
Time frame: each 6 months for up to 7 years
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
Time frame: at the end of surgery
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
Time frame: at 24 hours
Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII
Time frame: at 168 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Regional anesthesia in people with Breast Cancer Female, run by Azienda Ospedaliera San Gerardo di Monza.
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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Whole genome expression by microarray (time frame: before tumor excision). 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?
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 5 Aug 2020.