Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS

Study Purpose

This study is a prospective observational study evaluating the natural history of coronary plaque burden in participants with melanoma treated with ICI. The study will be conducted at various sites across Australia.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Capable of providing informed consent and willing to adhere to all protocol requirements.
  • - patients aged > or equal to 40 years.
  • - Histologically confirmed melanoma of any stage planned for, commenced, or completed treatment with ICI.
  • - having acceptable imaging quality deemed by the core laboratory.
  • - Investigator believes that the participant is willing to adhere to all protocol requirements, including returning for follow up CTCA.

Exclusion Criteria:

  • - Known clinically manifest cardiovascular disease.
  • - Female participants must not be pregnant, breastfeeding or plan to become pregnant during the study.
  • - Estimated glomerular filtration rate of <45 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.
  • - Severe liver disease or cirrhosis.
  • - History of any other malignancy within the past 5 years in addition to melanoma with the exception of non-melanoma skin cancers.
  • - Prognostic factors associated with an expected survival less than 18 months at Investigators' discretion (e.g. unresectable brain metastases) - Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study.
  • - Major allergy to iodine.
- Participation in another clinical trial that does not allow participation in multiple trials at the same time

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05180942
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Monash University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen J Nicholls, MBBS, PhD
Principal Investigator Affiliation Monash University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Atherosclerosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nepean Hospital, Kingswood 2161303, New South Wales 2155400, Australia

Status

Recruiting

Address

Nepean Hospital

Kingswood 2161303, New South Wales 2155400, 2747

Site Contact

Prakash Dhopte

[email protected]

+61 (0) 423245187

Calvary Mater Newcastle, Waratah 10103871, New South Wales 2155400, Australia

Status

Recruiting

Address

Calvary Mater Newcastle

Waratah 10103871, New South Wales 2155400, 2298

Site Contact

Joshua Bennetts

[email protected]

+61 (0) 423245187

Bundaberg Base Hospital, Bundaberg 2173323, Queensland 2152274, Australia

Status

Recruiting

Address

Bundaberg Base Hospital

Bundaberg 2173323, Queensland 2152274, 4670

Site Contact

Darren Nicholls

[email protected]

+61 (0) 423245187

Hervey Bay Hospital, Hervey Bay 6354957, Queensland 2152274, Australia

Status

Recruiting

Address

Hervey Bay Hospital

Hervey Bay 6354957, Queensland 2152274, 4655

Site Contact

Darren Nicholls

[email protected]

+61 (0) 423245187

Ipswich Hospital, Ipswich 2162644, Queensland 2152274, Australia

Status

Recruiting

Address

Ipswich Hospital

Ipswich 2162644, Queensland 2152274, 4305

Site Contact

Lisa Smith

[email protected]

+61 (0) 423245187

Toowoomba Hospital, Toowoomba 2146268, Queensland 2152274, Australia

Status

Recruiting

Address

Toowoomba Hospital

Toowoomba 2146268, Queensland 2152274, 4350

Site Contact

Kerry Blacket

[email protected]

+61 (0) 423245187

Queen Elizabeth Hospital, Woodville South 9973101, South Australia 2061327, Australia

Status

Recruiting

Address

Queen Elizabeth Hospital

Woodville South 9973101, South Australia 2061327, 5011

Site Contact

Pamela Cooper

[email protected]

+61 (0) 423245187

Monash Health, Clayton 2171400, Victoria 2145234, Australia

Status

Recruiting

Address

Monash Health

Clayton 2171400, Victoria 2145234, 3168

Site Contact

Mary-Anne Austin

[email protected]

+61 (0) 423245187

Peninsula Health, Frankston 2166144, Victoria 2145234, Australia

Status

Recruiting

Address

Peninsula Health

Frankston 2166144, Victoria 2145234, 3199

Site Contact

Judith Reilly

[email protected]

+61 (0) 423245187

Cabrini Health, Malvern 2158952, Victoria 2145234, Australia

Status

Recruiting

Address

Cabrini Health

Malvern 2158952, Victoria 2145234, 3144

Site Contact

Demis Balamatsias

[email protected]

+61 (0) 423245187

Peter MacCallum Cancer Centre, Melbourne 2158177, Victoria 2145234, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne 2158177, Victoria 2145234, 3051

Site Contact

Caroline Suhr

[email protected]

+61 (0) 423245187

Mildura Public Base Hospital, Mildura 2157698, Victoria 2145234, Australia

Status

Recruiting

Address

Mildura Public Base Hospital

Mildura 2157698, Victoria 2145234, 3500

Site Contact

Gemma Madigan

[email protected]

+61 (0) 423245187

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