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Chemo's hidden heart risk: study probes Cisplatin's effect on blood vessels

NCT ID NCT01453660

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looks at how the chemotherapy drug cisplatin affects the inner lining of blood vessels (the endothelium) in men with germ cell tumors. Researchers will measure blood vessel function in patients receiving cisplatin and compare them to a group who had surgery only. The goal is to better understand the link between cisplatin and long-term heart disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cisplatin chemotherapy
What this could lead to
If successful, this study could help explain how cisplatin causes long-term heart problems and point to ways to prevent them.
What could go wrong
This is a small, early pilot study that only measures short-term changes. It may not prove a clear link or lead to any new treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2011

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 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 Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

germ cell tumor Neoplasms, Germ Cell and Embryonal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.