Kanser Tedavisi Sonrası Genetik ve Kalp Sağlığı

Sade dilde özet

Bu çalışma, meme kanseri (breast cancer) tedavisi görmüş kişilerde BRCA1 ve BRCA2 gen durumunun kalp sağlığı ile ilişkisini ekokardiyografi, egzersiz testi ve kan örnekleri aracılığıyla incelemektedir. Çalışmaya, 2005 ve sonrasında meme kanseri tanısı almış, BRCA testi belgelenmiş 18 yaş üzeri hastalar katılmıştır. Çalışma Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Abramson Cancer Center at Penn Medicine

Müdahale

echocardiography, Cardiopulmonary Exercise Testing, Blood Collection

Başlangıç

05.12.2017

Tahmini bitiş

31.05.2022

Ülkeler

United States

İlgili genler

Merkezler

• Philadelphia, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria

* ≥18 years of age
* Initial diagnosis of Breast Cancer in 2005 or later
* Documented BRCA testing (results from a local laboratory are acceptable) showing

  * confirmation of a germline mutation in BRCA1 or BRCA2 that is predicted or suspected to be deleterious OR
  * confirmation that no mutation was detected in BRCA1 or BRCA2
* Non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen.
* Approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy
* Able to provide informed consent

Exclusion Criteria

* Stage IV Breast Cancer
* Genetic testing confirming a variant of unknown significance (VUS) or benign polymorphism in BRCA1 or BRCA2
* V02 Testing contraindicated for any reason, including:

  * Myocardial infarction (within past 3 months)
  * High-risk unstable angina;
  * High-risk or uncontrolled cardiac arrhythmias;
  * Symptomatic severe aortic stenosis;
  * Uncontrolled symptomatic heart failure;
  * Acute pulmonary embolus or pulmonary infarction;
  * Acute myocarditis or pericarditis;
  * Acute aortic dissection;
  * Coronary revascularization procedure within the past three months;
  * Uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg;
  * Clinically significant valvular heart disease (severe stenosis or regurgitation);
  * Known aortic aneurysm; or
  * Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the V02 test
* Women who are pregnant
* Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent