Testicular CancerINTELLECTNCT03557164
Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer
An observational study of Testicular Cancer and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Testicular Cancer, Cardiovascular Diseases, Cardiovascular Risk Factor
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 1 Jul 2018
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Study population: testicular cancer oncology patients
Who may be able to join
- Histological diagnosis of stage 1 low-risk germ cell testicular cancer treated with orchidectomy, or IGCCC good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer treated with orchidectomy (and or retroperitoneal surgery) plus cisplatin based chemotherapy, 12 - 18 months or 5 - 7 years previously.
- Aged between 18 and 50 years inclusive, at time of enrolment
Who cannot join
- Unable to provide written, informed consent
- Unable or unwilling to attend for investigations
- Current active involvement in a clinical trial
- Those receiving drug treatment for any vascular disease:
- o Including hypertension, hyperlipidaemia, cerebrovascular disease, ischaemic heart disease or heart failure
- Asthma
Show all 15Show fewer
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Arial fibrillation/flutter
- Oral anticoagulation therapy
- Cigarette smoker or tobacco use
- Recreational drug use
- Ongoing inflammatory, infective or autoimmune disease
- Other malignant disease diagnosed in previous 7 years
- Previous venous or arterial thrombotic/thromboembolic event
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
About this study
Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of VEGFI and cisplatin are unknown, but effects on vascular function may be important.
The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a variety of methods.
Read the detailed description
There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this study will inform its design.
The information gained from this pilot study will guide the development of interventional pharmacological studies that are directed towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with platinum based chemotherapy for testicular cancer.
- Medical subject headings
- Testicular Neoplasms, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
venous occlusion plethysmography assessment of endothelial function
expressed as ml per 100 ml of forearm volume per minute
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Mar 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Ninian Lang, MBChB PhD, Principal investigator, QEUH, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557164
- Sponsor's protocol ID
- 16/WS/0030
- Acronym
- INTELLECT
- Status last verified
- Nov 2019
- First submitted
- 4 Jun 2018
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cameron AC, McMahon K, Hall M, Neves KB, Rios FJ, Montezano AC, Welsh P, Waterston A, White J, Mark PB, Touyz RM, Lang NN. Comprehensive Characterization of the Vascular Effects of Cisplatin-Based Chemotherapy in Patients With Testicular Cancer. JACC CardioOncol. 2020 Sep;2(3):443-455. doi: 10.1016/j.jaccao.2020.06.004.
PubMed 33043304
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer
- ClinicalTrials.gov ID
- NCT03557164
- Acronym / sponsor ID
- INTELLECT / 16/WS/0030
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 14 Jun 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.
Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of VEGFI and cisplatin are unknown, but effects on vascular function may be important.
The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a variety of methods.
Detailed description
There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this study will inform its design.
The information gained from this pilot study will guide the development of interventional pharmacological studies that are directed towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with platinum based chemotherapy for testicular cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- testicular cancer oncology patients
Key inclusion criteria (2 listed)
- Histological diagnosis of stage 1 low-risk germ cell testicular cancer treated with orchidectomy, or IGCCC good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer treated with orchidectomy (and or retroperitoneal surgery) plus cisplatin based chemotherapy, 12 - 18 months or 5 - 7 years previously.
- Aged between 18 and 50 years inclusive, at time of enrolment
Key exclusion criteria (15 listed)
- Unable to provide written, informed consent
- Unable or unwilling to attend for investigations
- Current active involvement in a clinical trial
- Those receiving drug treatment for any vascular disease:
- o Including hypertension, hyperlipidaemia, cerebrovascular disease, ischaemic heart disease or heart failure
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
venous occlusion plethysmography assessment of endothelial function
Time frame: 8 weeks
expressed as ml per 100 ml of forearm volume per minute
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 25 Nov 2019.
- Derived from this study: PubMed 33043304Cameron AC, McMahon K, Hall M, Neves KB, Rios FJ, Montezano AC, Welsh P, Waterston A, White J, Mark PB, Touyz RM, Lang NN. Comprehensive Characterization of the Vascular Effects of Cisplatin-Based Chemotherapy in Patients With Testicular Cancer. JACC CardioOncol. 2020 Sep;2(3):443-455. doi: 10.1016/j.jaccao.2020.06.004.
- Individual participant dataSharing planned: Undecided
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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.
Ninian Lang, MBChB PhD principal investigator
QEUH, NHS Greater Glasgow and Clyde
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 Testicular Cancer and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 15 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 25 Nov 2019. 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 Kingdom. 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?
venous occlusion plethysmography assessment of endothelial function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557164, which also lists 1 linked publication.
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 25 Nov 2019.