Germ Cell CancerNCT01453660
Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
An observational study of Germ Cell Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Germ Cell Cancer
- What is being tested?
- Endo-PAT2000 testing
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2011to Oct 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The Cisplatin-Based Chemotherapy Group will be recruited from the Genitourinary (GU) oncology clinics. The GU Oncology section has a large clinical service which ensures adequate recruitment. The Surgery-Only Group will consist of patients with a diagnosis of GCT who have recently had surgical management of their disease and are not planned to receive radiation or chemotherapy. Potentially eligible patients will be recruited from the GU Oncology and Urology clinics since they are seen by both services.
Who may be able to join
- Cisplatin-Based Chemotherapy Group
- Histologically-proven diagnosis of GCT
- Male
- Age ≥18
- No prior exposure to chemotherapy or radiation
- Planned to receive 3-4 cycles of cisplatin-based chemotherapy
Show all 11Show fewer
- Surgery-Only Group
- Histologically-proven diagnosis of GCT Male
- Age ≥18
- Surgical management of GCT performed less than 90 days before start of study (includes orchiectomy and primary retroperitoneal lymph node dissection (RPLND))
- No prior exposure to chemotherapy or radiation
Who cannot join
- Cisplatin-Based Chemotherapy Group
- Prior exposure to chemotherapy or radiation
- Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease
- Surgery-Only Group
- Prior exposure to chemotherapy or radiation
- Planned for non-surgical management with chemotherapy or radiation.
- Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.
- Conditions
- Germ Cell Cancer
- Being tested
- Endo-PAT2000 testing
- Keywords
- Endothelial Function, Endo-PAT2000 system, 11-140
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-PAT2000 testingOther
Endo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1)
Endo-PAT2000 testingOther
Also called For any patients in Surgery-Only Group who relapse & enroll in the the, Cisplatin-Based Chemotherapy Group before the completion of the Surgery Group, End of Study Assessment, the Baseline Time 1 Chemotherapy Group Assessment can, will also serve as the End of Study Time 5 Surgery Group Assessment.
Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, \& urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure \& heart rate, including orthostatics \& Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, \& urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin-Based Chemotherapy Group | GCT patients who are planned to start cisplatin-based chemotherapy will be identified within the genitourinary oncology service clinics and offered inclusion in the trial. Receives: Other: Endo-PAT2000 testing | |
| Surgery-Only Group | GCT patients who have been treated with surgery and who do not require chemotherapy or radiation will be used as a comparison group to confirm that there is not a significant change in endothelial function among GCT patients treated with surgery alone. Receives: Other: Endo-PAT2000 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the endothelial reactivity (PAT-RH) in both groups
The Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard BP cuff).
Measured: 15 minutes
Secondary outcomes (3)
Identify sociodemographic
(age, race/ethnicity)
Measured: 2 years
Identify comorbid health conditions
Other laboratory studies being assessed in this trial will include lipid profile, testosterone, LH, FSH, and hemoglobin A1C. These tests are being evaluated to determine if there are concurrent comorbidities
Measured: 2 years
Measure PAT-RH index
at Time 6 (Long-Term Follow Up Assessment) in the Cisplatin-Based Chemotherapy Group and evaluate long term changes in PATRH index.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study start11 Oct 2011
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darren Feldman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453660
- Sponsor's protocol ID
- 11-140
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2011
- Last updated
- 10 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
- ClinicalTrials.gov ID
- NCT01453660
- Acronym / sponsor ID
- 11-140
- Conditions
- Germ Cell Cancer
- Keywords
- Endothelial Function, Endo-PAT2000 system, 11-140
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 11 Oct 2011 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- 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.
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin-Based Chemotherapy Group | – | Other: Endo-PAT2000 testingGCT patients who are planned to start cisplatin-based chemotherapy will be identified within the genitourinary oncology service clinics and offered inclusion in the trial. |
| Surgery-Only Group | – | Other: Endo-PAT2000 testingGCT patients who have been treated with surgery and who do not require chemotherapy or radiation will be used as a comparison group to confirm that there is not a significant change in endothelial function among GCT patients treated with surgery alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Cisplatin-Based Chemotherapy Group will be recruited from the Genitourinary (GU) oncology clinics. The GU Oncology section has a large clinical service which ensures adequate recruitment. The Surgery-Only Group will consist of patients with a diagnosis of GCT who have recently had surgical management of their disease and are not planned to receive radiation or chemotherapy. Potentially eligible patients will be recruited from the GU Oncology and Urology clinics since they are seen by both services.
Key inclusion criteria (11 listed)
- Cisplatin-Based Chemotherapy Group
- Histologically-proven diagnosis of GCT
- Male
- Age ≥18
- No prior exposure to chemotherapy or radiation
Key exclusion criteria (7 listed)
- Cisplatin-Based Chemotherapy Group
- Prior exposure to chemotherapy or radiation
- Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease
- Surgery-Only Group
- Prior exposure to chemotherapy or radiation
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 |
|---|---|---|
| Endo-PAT2000 testingEndo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1) | Other | Cisplatin-Based Chemotherapy Group |
| Endo-PAT2000 testingAlso: For any patients in Surgery-Only Group who relapse & enroll in the the, Cisplatin-Based Chemotherapy Group before the completion of the Surgery Group, End of Study Assessment, the Baseline Time 1 Chemotherapy Group Assessment can, will also serve as the End of Study Time 5 Surgery Group Assessment.Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, \& urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure \& heart rate, including orthostatics \& Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, \& urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1) | Other | Surgery-Only Group |
Primary outcome
Measure the endothelial reactivity (PAT-RH) in both groups
Time frame: 15 minutes
The Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard BP cuff).
3 secondary outcomes
Identify sociodemographic
Time frame: 2 years
Identify comorbid health conditions
Time frame: 2 years
Measure PAT-RH index
Time frame: 2 years
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 10 Nov 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Darren Feldman, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Germ Cell Cancer, run by Memorial Sloan Kettering Cancer Center 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 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. 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?
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?
Measure the endothelial reactivity (PAT-RH) in both groups (time frame: 15 minutes). 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 10 Nov 2025.