AnesthesiaEarly Phase 1NCT06626711
Effect of Propofol and Sevoflurane Anesthesia on HSP70 Expression in Tumor Cells
A Early Phase 1 study testing Propofol and Sevoflurane in people with Anesthesia and Cancer Recurrence, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
The goal of this clinical trial is to learn if sevoflurane-based inhalational anesthesia (s-IA) and propofol-based total intravenous anesthesia (p-TVA) have different effects on HSP70 expression in different types of tumour cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Cancer Recurrence, Cancer
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 10 Oct 2024to 30 Dec 2025
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed malignant neoplasm
- Planned surgery for radical or palliative tumor resection
- Age over 18 years
- Signed informed consent
Who cannot join
- Diabetes mellitus type 2
- HIV, hepatitis B or C
- Emergency surgery
- Known or suspected allergy to studied drugs
- Other conditions when one of the types of anesthesia is more preferable (hemodynamic disorders, bronchial asthma etc)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint Petersburg State University Hospital
Saint Petersburg, 1999034
About this study
Official title: Effect of Propofol and Sevoflurane Anesthesia on HSP70 Expression in Tumor Cells A Prospective, Single-center, Pilot, Randomized Study
The goal of this clinical trial is to learn if sevoflurane-based inhalational anesthesia (s-IA) and propofol-based total intravenous anesthesia (p-TVA) have different effects on HSP70 expression in different types of tumour cells. The main questions it aims to answer are:
- if p-TVA/s-IA increase or suppress HSP70 expression in tumor cells in comparison with a pre-anesthesia level;
- does this change in HSP70 expression cause any difference in vital characteristics of tumor cells, such as proliferation, apoptosis, colony formation and migration.
Read more
Researchers will compare p-TVA with s-IA by ability of these types of anesthesia to change the HSP70 expression level and modulate HSP70-mediated effects in tumor cells.
Participants will:
- be randomly allocated to p-TVA or s-IA groups;
- donate 12 ml of blood before anesthesia induction and 12 ml after 2 hours of anesthesia.
The blood serum will be used to prepare cell medium. After exposure to this medium, cells from different tumor types will be investigated using cytological and molecular biological methods.
Read the detailed description
This study will be conducted in adult cancer patients who undergo planned radical or palliative tumor resection and signed informed consent. Patients with diabetes mellitus, HIV, hepatitis B and C, as well as patients who undergo emergency surgery will not be included to the study. Patients will be randomly allocated to propofol-based TVA (p-TVA) and sevoflurane-based IA (s-IA) groups. After the collection of blood before the anesthesia induction and in 2 hours of anesthesia, probes will be centrifuged to prepare serum. Cell medium will contain 50% of blood serum. Different tumor cell lines (human lung adenocarcinoma A549, large cell lung carcinoma NCI-H460, human colorectal adenocarcinoma DLD1) will be exposed to the cell medium for 4 hours what corresponds to an approximate duration of anesthesia for oncology surgery. HSP70 expression level will be determined using SDS-PAGE (polyacrilamide gel electrophoresis) and Western-blot analysis (intracellular HSP70 content), ELISA of cell medium (extracellular HSP70 expression) and confocal microscopy.
The A549 cell line with stable knockdown of HSP70 developed by shRNA will be used to distinguish HSP70-based effects of cell medium from p-TVA and s-IA groups on vital characteristics of tumor cells, including proliferation (MTT assay), apoptosis (LDH cytotoxicity assay), colony formation and migration (the Wound healing assay).
Researchers will compare HSP70 expression levels and vital characteristics of tumor cells exposed to patient serum before and after each type of anesthesia, as well as p-TVA group with s-IA group.
- Conditions
- Anesthesia, Cancer Recurrence, Cancer
- Being tested
- Propofol, Sevoflurane
- Keywords
- Cancer, Anesthesia, Sevoflurane, Propofol
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol as a part of total venous anesthesia
SevofluraneDrug
Sevoflurane as a part of intravenous anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Propofol-based total venous anesthesia group | Experimental | These patients will receive total venous anethesia where propofol is used as a hypnotic drug. Receives: Drug: Propofol |
| Sevoflurane-based inhalational anesthesia group | Experimental | These patients will receive inhalational anethesia where sevoflurane is used as a hypnotic drug. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSP70 expression in tumor cells in vitro
Increased intracellular and extracellular HSP70 content in different types of tumor cells measured by SDS-PAGE/Western blotting and ELISA, respectively.
Measured: 24 hours after exposition with patients serum.
Secondary outcomes (4)
LDG cytotoxicity
Reduction of apoptosis mediated by HSP70 pathway in different types of tumor cells measured by LDG cytotoxicity assay using HSP70-knockdown cell line.
Measured: 24 hours after exposition with patients serum.
MTT test
Increase in proliferation mediated by HSP70 pathway in different types of tumor cells measured by MTT assay using HSP70-knockdown cell line.
Measured: 24 hours after exposition with patients serum.
Wound healing test
Increase in cell migration mediated by HSP70 pathway in different types of tumor cells measured by the Wound healing assay.
Measured: 72 hours after exposition with patients serum.
Cell colonies formation
Increase in ability to form colonies mediated by HSP70 pathway in different types of tumor cells evaluated by direct microscopy using HSP70-knockdown cell line.
Measured: 7 days after exposition with patients serum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Oct 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cytology of the Russian Academy of Sciences, The Russian Science Foundation
- Responsible party
- Principal investigator, Efremov Sergey, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626711
- Sponsor's protocol ID
- 23-25-00078
- Status last verified
- Apr 2025
- First submitted
- 2 Oct 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol and Sevoflurane Anesthesia on HSP70 Expression in Tumor Cells A Prospective, Single-center, Pilot, Randomized Study
- ClinicalTrials.gov ID
- NCT06626711
- Acronym / sponsor ID
- 23-25-00078
- Conditions
- Anesthesia, Cancer Recurrence, Cancer
- Keywords
- Cancer, Anesthesia, Sevoflurane, Propofol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Collaborators
- Institute of Cytology of the Russian Academy of Sciences, The Russian Science Foundation
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
The goal of this clinical trial is to learn if sevoflurane-based inhalational anesthesia (s-IA) and propofol-based total intravenous anesthesia (p-TVA) have different effects on HSP70 expression in different types of tumour cells. The main questions it aims to answer are:
- if p-TVA/s-IA increase or suppress HSP70 expression in tumor cells in comparison with a pre-anesthesia level;
- does this change in HSP70 expression cause any difference in vital characteristics of tumor cells, such as proliferation, apoptosis, colony formation and migration.
Researchers will compare p-TVA with s-IA by ability of these types of anesthesia to change the HSP70 expression level and modulate HSP70-mediated effects in tumor cells.
Participants will:
- be randomly allocated to p-TVA or s-IA groups;
- donate 12 ml of blood before anesthesia induction and 12 ml after 2 hours of anesthesia.
The blood serum will be used to prepare cell medium. After exposure to this medium, cells from different tumor types will be investigated using cytological and molecular biological methods.
Detailed description
This study will be conducted in adult cancer patients who undergo planned radical or palliative tumor resection and signed informed consent. Patients with diabetes mellitus, HIV, hepatitis B and C, as well as patients who undergo emergency surgery will not be included to the study. Patients will be randomly allocated to propofol-based TVA (p-TVA) and sevoflurane-based IA (s-IA) groups. After the collection of blood before the anesthesia induction and in 2 hours of anesthesia, probes will be centrifuged to prepare serum. Cell medium will contain 50% of blood serum. Different tumor cell lines (human lung adenocarcinoma A549, large cell lung carcinoma NCI-H460, human colorectal adenocarcinoma DLD1) will be exposed to the cell medium for 4 hours what corresponds to an approximate duration of anesthesia for oncology surgery. HSP70 expression level will be determined using SDS-PAGE (polyacrilamide gel electrophoresis) and Western-blot analysis (intracellular HSP70 content), ELISA of cell medium (extracellular HSP70 expression) and confocal microscopy.
The A549 cell line with stable knockdown of HSP70 developed by shRNA will be used to distinguish HSP70-based effects of cell medium from p-TVA and s-IA groups on vital characteristics of tumor cells, including proliferation (MTT assay), apoptosis (LDH cytotoxicity assay), colony formation and migration (the Wound healing assay).
Researchers will compare HSP70 expression levels and vital characteristics of tumor cells exposed to patient serum before and after each type of anesthesia, as well as p-TVA group with s-IA group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-based total venous anesthesia group | Experimental | Drug: PropofolThese patients will receive total venous anethesia where propofol is used as a hypnotic drug. |
| Sevoflurane-based inhalational anesthesia group | Experimental | Drug: SevofluraneThese patients will receive inhalational anethesia where sevoflurane is used as a hypnotic drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed malignant neoplasm
- Planned surgery for radical or palliative tumor resection
- Age over 18 years
- Signed informed consent
Key exclusion criteria (5 listed)
- Diabetes mellitus type 2
- HIV, hepatitis B or C
- Emergency surgery
- Known or suspected allergy to studied drugs
- Other conditions when one of the types of anesthesia is more preferable (hemodynamic disorders, bronchial asthma etc)
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 |
|---|---|---|
| PropofolPropofol as a part of total venous anesthesia | Drug | Propofol-based total venous anesthesia group |
| SevofluraneSevoflurane as a part of intravenous anesthesia | Drug | Sevoflurane-based inhalational anesthesia group |
Primary outcome
HSP70 expression in tumor cells in vitro
Time frame: 24 hours after exposition with patients serum.
Increased intracellular and extracellular HSP70 content in different types of tumor cells measured by SDS-PAGE/Western blotting and ELISA, respectively.
4 secondary outcomes
LDG cytotoxicity
Time frame: 24 hours after exposition with patients serum.
MTT test
Time frame: 24 hours after exposition with patients serum.
Wound healing test
Time frame: 72 hours after exposition with patients serum.
Cell colonies formation
Time frame: 7 days after exposition with patients serum.
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 4 May 2025.
- Individual participant dataSharing planned: Yes
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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?
A Early Phase 1 study testing Propofol and Sevoflurane in people with Anesthesia and Cancer Recurrence, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. 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 Russia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
HSP70 expression in tumor cells in vitro (time frame: 24 hours after exposition with patients serum.). 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 4 May 2025.