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Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652973
Recruitment Status : Active, not recruiting
First Posted : December 4, 2020
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.

Objective:

To measure atherosclerotic plaques on CECT in a group of males.

Eligibility:

Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.

Design:

This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.

Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.

The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.

This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.


Condition or disease
Prostatic Neoplasms

Detailed Description:

Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients.

Study Description:

This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient.

Objectives:

Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT).

Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.

Study Population:

Up to 1,000 NIH Clinical Center patients.

Description of Sites/Facilities conducting research:

NIH Clinical Center

Study Duration:

10 years

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evaluation of Atherosclerotic Plaques in Abdominal CT Studies
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : August 30, 2030
Estimated Study Completion Date : August 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
1/Prostate cancer dataset
Biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center.
2/Multiphase CT dataset
Men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.



Primary Outcome Measures :
  1. 1/Measure atherosclerotic plaques [ Time Frame: End of study ]
    Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)


Secondary Outcome Measures :
  1. 2/Plaque measurement and clinical biomarkers correlation [ Time Frame: End of study ]
    Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Two separate study populations were recruited. The "Prostate cancer dataset" consisted of biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. Men of all ages and races are included. The "Multiphase CT dataset" consisted of men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.
Criteria
  • INCLUSION CRITERIA:

The study will use existing radiologic data.

EXCLUSION CRITERIA:

NONE


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652973


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Ronald M Summers, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT04652973    
Other Study ID Numbers: 10000123
000123-CC
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: October 7, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
CT measurement
CVD
CT coronary angiogram
clinical biomarkers
Natural History
Additional relevant MeSH terms:
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Prostatic Neoplasms
Plaque, Atherosclerotic
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Pathological Conditions, Anatomical