Daha İyi Tedavi Seçimi İçin Pankreas Kanseri Hastalarında Gen Değişikliklerinin ve Özelliklerinin İncelenmesi

Sade dilde özet

Bu çalışma, pankreas kanseri (pancreatic cancer) hastalarında genlerdeki değişiklikleri ve özellikleri moleküler profilleme (molecular profiling) yöntemiyle inceleyerek daha iyi tedavi seçimine katkı sağlamayı amaçlamıştır. Çalışmaya, lokal ileri veya metastatik pankreas duktal adenokarsinomu (pancreatic ductal adenocarcinoma) olan, 18 yaş ve üzeri, biyopsiye uygun ve birinci basamak sistemik tedavi görecek hastalar alınmıştır. Çalışma faz uygulanmayan bir araştırma 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

University Health Network, Toronto

Müdahale

Molecular Profiling

Başlangıç

01.12.2015

Tahmini bitiş

01.08.2025

Ülkeler

Canada

İlgili genler

Merkezler

• Kingston, Canada
• Toronto, Canada
• Montreal, Canada
• Montreal, Canada

Uygunluk kriterleri

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

Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
* Patient must have a tumor lesion that is amenable to a core needle biopsy.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit enough to safely undergo a tumor biopsy.
* Age 18 years or older.
* Eastern Cooperative Group (ECOG) performance status of 1 or less.
* Life expectancy of greater than 90 days.
* Patients must have normal organ and marrow function
* Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
* Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients with one or more contraindications to tumor biopsy.
* Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
* Patients who are currently on anti-cancer treatment including chemotherapy.
* Patients with known brain metastases.
* Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.