High Blood PressureNCT04681560
Impact of Platinum-based Cancer Treatment on Endothelial Function
An observational study of High Blood Pressure and Cardiovascular Complication, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
Trial summary
In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure, Cardiovascular Complication
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- 18 Jan 2018to 20 Jan 2020
- 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: In this study included 60 patients, that have diagnosis solid cancer of any stage and localisation.All of them is expected to start platinum based or non platinum based chemotherapy.The study proseeds in Chemotherapy department at City Hospital No.1.
Who may be able to join
- Subject has solid cancer
- Subject is expected to start chemotherapy
Who cannot join
- Pregnancy and lactation
- Severe impaired kidney function
- Severe hepatic impairment
- Mental disease
- Acute myocardial infarction 28 days ago or earlier
- Acute Cerebrovascular Event 1 month ago or earlier
- Rhythm disturbance that complicate pulse wave velocity evaluation
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Olga Andreeva
Moscow, 119421
First Moscow State Medical University.
Moscow
About this study
Official title: The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.
In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.
Read the detailed description
The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.
Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.
Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.
Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.
- Conditions
- High Blood Pressure, Cardiovascular Complication
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of blood pressure
Both systolic and diastiolic blood pressure were measured in the office in the seated position, noninvasively.
Measured: Before start of chemotherapy (1 hour after including in the trial)
Evaluation of flow-mediated vasodilation and pulse-wave velocity
Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.
Measured: Before start of chemotherapy (1 hour after including in the trial)
Evaluation of concetration of ENOS and Big Endothelin in blood sampling
Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.
Measured: Before start of chemotherapy (1 hour after including in the trial)
Secondary outcomes (3)
Evaluation of blood pressure
Both systolic and diastiolic blood pressure was measured in the office in the seated position, noninvasively.
Measured: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of flow-mediated vasodilation and pulse-wave velocity
Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.
Measured: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of concetration of ENOS and Big Endothelin of blood sampling
Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.
Measured: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start18 Jan 2018
- Primary completion9 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitry Shchekochikhin, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681560
- Sponsor's protocol ID
- 1019
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.
- ClinicalTrials.gov ID
- NCT04681560
- Acronym / sponsor ID
- 1019
- Conditions
- High Blood Pressure, Cardiovascular Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 23 Dec 2020 (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.
In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.
Detailed description
The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.
Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.
Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.
Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study included 60 patients, that have diagnosis solid cancer of any stage and localisation.All of them is expected to start platinum based or non platinum based chemotherapy.The study proseeds in Chemotherapy department at City Hospital No.1.
Key inclusion criteria (2 listed)
- Subject has solid cancer
- Subject is expected to start chemotherapy
Key exclusion criteria (7 listed)
- Pregnancy and lactation
- Severe impaired kidney function
- Severe hepatic impairment
- Mental disease
- Acute myocardial infarction 28 days ago or earlier
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
Evaluation of blood pressure
Time frame: Before start of chemotherapy (1 hour after including in the trial)
Both systolic and diastiolic blood pressure were measured in the office in the seated position, noninvasively.
Evaluation of flow-mediated vasodilation and pulse-wave velocity
Time frame: Before start of chemotherapy (1 hour after including in the trial)
Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.
Evaluation of concetration of ENOS and Big Endothelin in blood sampling
Time frame: Before start of chemotherapy (1 hour after including in the trial)
Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.
3 secondary outcomes
Evaluation of blood pressure
Time frame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of flow-mediated vasodilation and pulse-wave velocity
Time frame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of concetration of ENOS and Big Endothelin of blood sampling
Time frame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
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 2020.
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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.
Dmitry Shchekochikhin, PhD principal investigator
I.M. Sechenov First Moscow State Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Pressure and Cardiovascular Complication, run by I.M. Sechenov First Moscow State Medical University at 2 sites 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 2 inclusion and 7 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 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Evaluation of blood pressure (time frame: Before start of chemotherapy (1 hour after including in the trial)). The study lists 3 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 23 Dec 2020.