Monitoring heart health in patients receiving immune checkpoint inhibitors for gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows female patients aged 18 to 75 with gynecologic malignancies who are starting treatment with immune checkpoint inhibitors (ICIs). It involves a prospective cohort design where cardiac magnetic resonance (CMR) imaging and other assessments are conducted before and after the initiation of ICIs therapy. The study aims to evaluate changes in cardiac function and predict long-term outcomes related to cardiotoxicity. Multiple assessments will occur throughout the treatment process and during follow-up to monitor cardiac health and potential adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
* 2\. Patients who are preparing for monotherapy or combination therapy with ICIs.
* 3\. Voluntary signing of informed consent form.
* 4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 5\. Expected survival of at least 6 months.

Exclusion Criteria:

* 1\. Previously received ICIs treatment.
* 2\. With allergies or contraindications to ICIs.
* 3\. Confirmed to be brain metastasis.
* 4\. Patients who have major surgery within 4 weeks prior to or following the screening period.
* 5\. Patients who have received systemic corticosteroids (at a dose equivalent to \>10 mg prednisone per day) or other immunosuppressive medications within 14 days prior to enrollment or during the study period; however, the following situations are allowed for inclusion:

  1. the use of topical or inhaled corticosteroids is permitted;
  2. short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.
* 6\. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
* 7\. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
* 8\. Lack of autonomous capacity, or a documented history of mental disease.
* 9\. MRI contraindications: Pacemakers, neurostimulators, artificial metal heart valves, arterial aneurysm clips, intraocular metallic foreign bodies, inner ear implants, metal prostheses, metal limbs, metal joints, and any other metallic implants or foreign objects; severe hyperthermia patients; claustrophobia; severe respiratory conditions that prevent breath-holding.

Where it's running

• West China Second University Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Lu Ye
• Email: cltwo@163.com
• Phone: 86-028-88570418

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.