Testicular CancerNCT05611307
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
An observational study of Testicular Cancer and Survivorship, run by Indiana University at 1 site in United States.
Trial summary
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Testicular Cancer, Survivorship, ASCVD
- What is being tested?
- Lipid profile, Coronary artery assessment and Hormone levels for hypogonadism
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to Mar 2028
- Phase
- Observational
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Testicular Cancer Patients who are disease free more than 5 years after diagnosis and treatment
Who may be able to join
- Patients >18 years of age
- Patients will be recruited only if cancer-free at clinical evaluation time.
- For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)
- For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT \& BMT group, Arm 3).
- For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical/surveillance, Arm 1)
Who cannot join
- Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
- Significant renal disease (GFR<40)
- Allergy to iodinated contrast
- Antecedent chemotherapy for another primary cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Elizabeth Rowe, (317) 278-1185, rowee@iu.edu
About this study
Official title: Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Read the detailed description
Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 5 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.
- Conditions
- Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease, Lipid Disorder, Hypogonadism, Male
- Being tested
- Lipid profile, Coronary artery assessment, Hormone levels for hypogonadism
- Medical subject headings
- Testicular Neoplasms, Coronary Artery Disease, Lipid Metabolism Disorders, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid profileDiagnostic test
Advanced lipid profile
Coronary artery assessmentDiagnostic test
Coronary artery assessment via CT scans
Hormone levels for hypogonadismDiagnostic test
Hormone levels for hypogonadism
| Study group | Role | What they receive |
|---|---|---|
| Surgical/Surveillance | TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) Receives: Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism | |
| Cisplatin-based chemotherapy (CBCT) | TCS treat with one or more lines of cisplatin-based chemotherapy Receives: Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism | |
| Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT) | TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant Receives: Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws
Measured: More than 5 years after testicular cancer diagnosis, At recruitment
Coronary plaque assessment
Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans
Measured: More than 5 years after testicular cancer diagnosis, At recruitment
Secondary outcomes (2)
Hormone levels
Measurement of testosterone
Measured: More than 5 years after testicular cancer diagnosis, At recruitment
Serum platinum
Measurement of residual serum platinum levels
Measured: More than 5 years after testicular cancer diagnosis, At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start11 Oct 2022
- Primary completionJul 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), JDS Foundation Testis Cancer Clinical Trials Support Fund
- Responsible party
- Principal investigator, Noah Richardson, Indiana University
- Investigators
- Noah Richardson, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611307
- Sponsor's protocol ID
- 12751
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
- ClinicalTrials.gov ID
- NCT05611307
- Acronym / sponsor ID
- 12751
- Conditions
- Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease, Lipid Disorder, Hypogonadism, Male
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), JDS Foundation Testis Cancer Clinical Trials Support Fund
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Nov 2022 (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.
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Detailed description
Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 5 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical/Surveillance | – | Diagnostic Test: Lipid profile, Diagnostic Test: Coronary artery assessment, Diagnostic Test: Hormone levels for hypogonadismTCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) |
| Cisplatin-based chemotherapy (CBCT) | – | Diagnostic Test: Lipid profile, Diagnostic Test: Coronary artery assessment, Diagnostic Test: Hormone levels for hypogonadismTCS treat with one or more lines of cisplatin-based chemotherapy |
| Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT) | – | Diagnostic Test: Lipid profile, Diagnostic Test: Coronary artery assessment, Diagnostic Test: Hormone levels for hypogonadismTCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Testicular Cancer Patients who are disease free more than 5 years after diagnosis and treatment
Key inclusion criteria (5 listed)
- Patients >18 years of age
- Patients will be recruited only if cancer-free at clinical evaluation time.
- For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)
- For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT \& BMT group, Arm 3).
- For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical/surveillance, Arm 1)
Key exclusion criteria (4 listed)
- Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
- Significant renal disease (GFR<40)
- Allergy to iodinated contrast
- Antecedent chemotherapy for another primary cancer.
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 |
|---|---|---|
| Lipid profileAdvanced lipid profile | Diagnostic test | Cisplatin-based chemotherapy (CBCT), Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT), Surgical/Surveillance |
| Coronary artery assessmentCoronary artery assessment via CT scans | Diagnostic test | Cisplatin-based chemotherapy (CBCT), Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT), Surgical/Surveillance |
| Hormone levels for hypogonadismHormone levels for hypogonadism | Diagnostic test | Cisplatin-based chemotherapy (CBCT), Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT), Surgical/Surveillance |
Primary outcome
Lipid profile
Time frame: More than 5 years after testicular cancer diagnosis, At recruitment
HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws
Coronary plaque assessment
Time frame: More than 5 years after testicular cancer diagnosis, At recruitment
Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans
2 secondary outcomes
Hormone levels
Time frame: More than 5 years after testicular cancer diagnosis, At recruitment
Serum platinum
Time frame: More than 5 years after testicular cancer diagnosis, At recruitment
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 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Testicular Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Germ Cell Tumor and Testicular Tumor DNA Registry
Germ Cell Tumor, Testicular Tumor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingObservational study
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Malignant Testicular Germ Cell Tumor
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.
Noah Richardson, MD principal investigator
Indiana University
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 Survivorship, run by Indiana University at 1 site in United States.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 States. 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?
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?
Contact Elizabeth Rowe (317-278-1185, rowee@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: More than 5 years after testicular cancer diagnosis, At recruitment). The study lists 2 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 30 Oct 2026.